`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/088,756
`
`11/04/2020
`
`Alan R. Dombrowski
`
`7T8958US009
`
`4354
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`VU, QUYNH-NHU HOANG
`
`ART UNIT
`
`3783
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/18/2023
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`Thetime period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`LegalUSDocketing @ mmm.com
`
`PTOL-90A (Rev. 04/07)
`
`
`
`Office Action Summary
`
`Application No.
`17/088 ,756
`Examiner
`QUYNH-NHU H VU
`
`Applicant(s)
`Dombrowskietal.
`Art Unit
`AIA (FITF) Status
`3783
`Yes
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`
`
`1) Responsive to communication(s) filed on 11/04/2020.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3)02 An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)\0) Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`1-17 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) ___ is/are withdrawn from consideration.
`Cj} Claim(s)
`is/are allowed.
`Claim(s) 1-17 is/are rejected.
`S)
`) © Claim(s)___is/are objected to.
`Cj) Claim(s
`are subjectto restriction and/or election requirement
`)
`S)
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://Awww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`Application Papers
`10) The specification is objected to by the Examiner.
`11)0) The drawing(s) filedon__ is/are: a)(J accepted or b)( objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)1) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)Z None ofthe:
`b)() Some**
`a)C All
`1... Certified copies of the priority documents have been received.
`2.1) Certified copies of the priority documents have beenreceived in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) (J Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20230329A
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`The presentapplication, filed on or after March 16, 2013, is being examined under the first
`
`inventor to file provisions of the AIA.
`
`Election/Restrictions
`
`Applicant's election with traverse of species of Figs. 1-3B in the reply filed on 08/01/23 is
`
`acknowledged. The traversal is on the ground(s) that the species of Figs. 1-3B, species of Figs. 4A-4D,
`
`species of Figs. 5A-5B and species of Fig. 6 would require substantial duplication of work on the part of
`
`the U.S Patent Office. This is not found persuasive becauseof the reasonsasfollows:
`
`a) the caps 100 (Figs. 1A-2B), 500 (Figs. 4A-4D), 500 (Figs. 5A-5B) & 600 (Fig. 6) have different
`
`configuration.
`
`For example: comparing the different in the caps 100 & 500: In Figs1-2A, the cap 100 includes
`
`an opening 112 in the male post 120. Meanwhile, the cap 500 includes a closed end male post 120. In
`
`Fig. 5B, the bottom 130 of the chamber 1 14a includes a male post aperture 125, wherein the bottom 130
`
`of the chamber 114 in Fig. 1B has a solid base 132 of the male post 120.
`
`Comparingthe different in the cap 500 (in Figs. 4A-4D) and the cap 500 (in Figs. 5A-5B): the
`
`cap 500 (in Figs. 4A-4D) does notinclude a gripping feature. Meanwhile, the cap 500 (Figs. 5A-5B)
`
`includes a gripping feature 110. A top/sealing surface of the cap 500 in Fig. 4A (wherein the seal 103
`
`covers and contacts the top surface in Fig. 4A)is flat surface. Meanwhile, the top sealing surface 105 of
`
`the cap 500 in Fig. 5A is tapered and inclined inwardly.
`
`Note: claim 11 requires that: a terminal end surface(i.e. element 120 in Fig. 4A or element 520 in
`
`Fig. 5A) of the male post facing the opening 112 is solid. This feature has described in the non-elected
`
`species in Figs. 4A-5B.
`
`It is further noticed that the terminal end 120 of the male post 120 (in Fig. 1)
`
`facing the opening 112 defines an opening, see Fig. 2A. Therefore, the claim 11 is withdrawn.
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 3
`
`Comparing the caps 100, 500 & 600: as seen in Fig. 6, the cap 600 clearly showsthatit hasits
`
`own feature with different structure and different configuration.
`
`For all reason above, the capsin different species require different search queries.
`
`b) Examiner stated on page 3 of the Restriction/Election Requirement 05/01/23 that:
`
`“Should applicant traverse on the groundthat the species, or groupings of patentably indistinct species
`
`from which election is required, are not patentably distinct, applicant should submit evidence oridentify
`
`such evidence now of record showing them to be obvious variants or clearly admit on the record that this
`
`is the case. In either instance, if the examinerfinds one of the species unpatentable over the prior art, the
`
`evidence or admission may be usedin a rejection under 35 U.S.C. 103 or pre-AlA 35 U.S.C. 103(a) of the
`
`other species.”
`
`Because applicant did not distinctly and specifically point out the supposed errors in the
`
`restriction requirement. In addition, applicant did not submit evidenceor identify that the species above
`
`are obvious variants, as indicated in the statement above. Therefore, the election has been treated as an
`
`election without traverse (MPEP § 818.01(a)).
`
`Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to
`
`a nonelected species of Figs, 4A-6, there being no allowable generic or linking claim. Applicant timely
`
`traversed the restriction (election) requirementin the reply filed on 08/01/23.
`
`Note: although the piston 300 only showsin the Figs. 4A-4B, however, the piston 300 can be
`
`positioned in the elected Fig. 1-2B. The claims 14 & 16 require the generic cap that can be read on either
`
`Fig. 1-4D. The claims 14-17 do not require the difference species feature in the non-elected of Figs. 4A-
`
`4D such as: a terminal end surface 120 of the male post facing the opening 112 is solid (or not opening).
`
`In this case, the claims 14-17 should be examinedin this office.
`
`Therefore, the claims 1-10, 12-17 are being examinedin this office action.
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 4
`
`Claim Rejections - 35 USC § 112
`
`The following is a quotation ofthe first paragraph of 35 U.S.C. 112(a):
`
`(a) INGENERAL.—The specification shall contain a written description of the
`invention, and of the manner and process of making and usingit, in such full, clear, concise,
`and exact terms as to enable any person skilled in the art to which it pertains, or with whichit
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor or joint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AlA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the
`manner and process of making and usingit, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with whichit is most nearly
`connected, to make and use the same, and shall set forth the best mode contemplated by the
`inventor of carrying out his invention.
`
`Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, because
`
`the specification, while being enabling for a constrained region where the bodyof the capis indirect
`
`contact with the wall of the chamber proximate the opening and an unconstrained region where
`
`the body of the cap is spaced apart from the wall of the chamber, does not reasonably provide
`
`enablementfor; and the thread in the constrained region has a height lower than a height of the
`
`thread in the unconstrained region. The specification does not enable any person skilled in the art to
`
`whichit pertains, or with whichit is most nearly connected, to make the invention commensurate in scope
`
`with these claims.
`
`The claim 5 recited that: an unconstrained region where the body of the cap is spaced apart from
`
`the wall of the chamber.
`
`In other words, the unconstrained region is equivalent to a region 108 (in Fig.
`
`2A, the body of the cap is spaced apart from the wall of the chamber).
`
`It is noted that the thread is
`
`located or apart of the wall 116 of the chamber. Howis possible that the thread being located in the
`
`constrained region 108? As shownin Fig. 2B, the threads H2-H3 are parts of the wall of the chamber and
`
`defined as unconstrained region 142.
`
`In that case, the threads H2-H3 (or the unconstrained region 142)
`
`is not spaced apart from the wall of the chamber
`
`In addition, all of the threads are located at H1-H3. It is unclear to Examiner that howis the
`
`“constrained region” and “unconstrained region” being define when all of the threads H1-H4 do not
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 5
`
`include any special feature of threads. The threads H1-H9arein different height but they are not
`
`necessary to define as “constrained region” and “unconstrained region”.
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`Claims 3-4 recites the limitation "the top region"in the last line of the claim 3. Thereis insufficient
`
`antecedent basis for this limitation in the claim.
`
`It is unclear to Examiner that the limitation “the top region” in the claims 3-4 is whether same or
`
`different with the limitation “a top region” (of the movable piston), as recited in the claim 2.
`
`In claim 3, it requires that: a plurality of ribs... Does applicant mean the “plurality of ribs” of the
`
`movable piston or the “plurality of ribs” of the cap?
`
`Claim 16 recites the limitation "the sealing surface"in the last two lines of the claim 16. There is
`
`insufficient antecedent basis for this limitation in the claim.
`
`Claims 15 & 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second
`
`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter
`
`whichthe inventor or a joint inventor (or for applications subject to pre-AlA 35 U.S.C. 112, the applicant),
`
`regards as the invention.
`
`In claim 15, the limitation “an engagement mechanism comprising a thread” is vague. It is
`
`unclear to Examiner that the limitation “thread” in claim 15 is whether same or different with the limitation
`
`“a thread” in the independent claim 14.
`
`In caseif the limitation “thread”in the claim 15 is different with the
`
`“thread”in the claim 14, Applicant is requested to point out that which element is equivalent to the
`
`“thread”limitation in the claim 15.
`
`Similarly, it is unclear that the limitation “wherein at least a portion of the thread’in claim 15 is
`
`whether same ordifferent with the limitation “at least a portion of the thread”in the claim 14.
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 6
`
`In claim 17, it depends on the independentclaim 16; wherein the claim 17 recites “a sealing
`
`surface”.
`
`It is unclear to Examiner that the limitation “a sealing surface”in claim 17 is whether same or
`
`different with the limitation “the sealing surface” in the claim 16.
`
`Claim Rejections - 35 USC § 103
`
`In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and
`
`103 (or as subject to pre-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for
`
`the rejection will not be considered a new groundofrejection if the prior art relied upon, and the rationale
`
`supporting the rejection, would be the same under either status.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousnessrejections
`
`setforth in this Office action:
`
`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention andthe prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall not be
`negated by the manner in which the invention was made.
`
`Claims 1-3, 5-10, 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over
`
`Mermet (US 2004/0261872) in view of Ziebolet al. (US 8,622,995).
`
`Regarding claim 1, Mermetdiscloses a cap 2 configured for removable attachment a medical
`
`device 3, in Figs. 1-6, the cap 2 comprising:
`
`a body 10 comprising an opening (at 10 or 11 in Fig. 5), a bottom 13 (Fig. 2), and a chamber (an
`
`interior space of the wall 11) defined between the opening 10/11 and the bottom 13;
`
`a male post 12 in the chamber and projecting from the bottom 13 towards the opening of the
`
`body;
`
`a wall 11 of the chamber comprising a thread a-d (see marked-up figure below) originating
`
`proximate the opening and extending into the chamber, wherein the male post 12 is spaced from the wall
`
`11 and at least a portion of the thread a-d having a height that increases as a function of increasing
`
`distance from the opening; and
`
`a movable piston 4 positioned about the male post;
`
`
`
`Page 7
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`
`
`Mermetdoes not disclosealiquid disinfectant in the chamber between the bottom of the body
`
`and the movable piston.
`
`Ziebol discloses a cap 120 in Figs. 17-22 comprising: a body comprising an opening 192 (Fig. 17)
`
`and bottom (opposite side of the opening 192); a chamber 194; a male post located inside the chamber
`
`194, see similar figure 21; a liquid disinfectant 191 contains antimicrobial residue 291 in the chamber 194
`
`at the bottom of the chamber or in between the bottom of the body and the opening, see Figs. 17-22.
`
`It would have been obvious to one of ordinary skill in the art, prior to the effectivefilling date of the
`
`claimed invention to modify the device of Mermet with providing a liquid disinfectant in the chamber, as
`
`taught by Ziebol, in order to kill a broad spectrum of organisms, col. 23, lines 16-18.
`
`Thus, Mermetin view of Ziebol disclosesthat a liquid disinfectant (as modified by Ziebol) is
`
`located inside the chamber 11 of the cap 2. In other words, the liquid disinfectantis in the chamber
`
`between the bottom 13/24 of the body and the movable piston 4.
`
`Regarding claim 2, Mermetin view of Ziebol disclosesall the claimed subject matter as required.
`
`Mermetfurther discloses that wherein the movable piston 4 comprises: a central opening (an interior
`
`space of a stud 50, adjacent to element 51) with an interferencefit (at an inner surface of the stud 50)
`
`surrounding the male post 12; a top region 50 extending from the central opening and comprising a
`
`sealing surface (an inner surface of the stud 50 and outer surface 51); and a flexible circumferential skirt
`
`52 in slidable contact with the wall of the chamber, see Fig. 6 in Mermet.
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 8
`
`Regarding claim 3, as best as understood, a plurality of ribs/threads positioned about/near a
`
`periphery of a top region (e.g. the top region 10 or the top region 11 or the top region 50)
`
`Regarding claim 5, as best as understood, Mermetin view of Ziebol disclosesall the claimed
`
`subject matter as required. Mermetfurther discloses that wherein: the body comprises a constrained
`
`region 11 where the body of the capis in direct contact with the wall of the chamber proximate the
`
`opening and an unconstrained region 11 (and/or outer surface of the body, adjacent to element2 in Fig.
`
`5) where the body of the cap is spaced apart from the wall 11 of the chamber; and the thread in the
`
`constrained region a1 has a height lower than a height of the thread b-d in the unconstrained region.
`
`
`
`Regarding claim 6, Mermetin view of Ziebol disclosesall the claimed subject matter as required.
`
`Mermetdiscloses in the marked-up figure above that wherein: the thread comprisesa first portion (a) and
`
`a second portion (b or c or d); the first portion is closer to the opening than the second portion. It appears
`
`in the marked-up figure above that the second portion has a heightthat is at least about 50%higher than
`
`the first portion.
`
`In addition, it would have been obvious to one having ordinary skill in the art at the time
`
`of the invention was made to obtain a second thread being at least 50%-150%higher than the first portion
`
`thread, since it has been held that discovering these values aboveof a result effective variable involves
`
`only routine skill in the art.
`
`Regarding claim 7, Mermetin view of Ziebol disclosesall the claimed subject matter as
`
`required. Mermet discloses that the thread a-d has a radiused surface.
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 9
`
`Regarding claim 8, Mermetin view of Ziebol disclosesall the claimed subject matter as required.
`
`Mermet discloses that wherein: the body 10 comprises an exterior wall; and an annular gap (a space in
`
`between elements 10 & 11 in Fig. 5 in Mermet) is defined between the chamber and the exterior wall, the
`
`annular gap extending axially between the opening and the bottom.
`
`Regarding claim 9, Mermetfurther discloses that wherein the annular gap is configured to
`
`accommodate flexing of the chamber.
`
`Regarding claim 10, Mermetin view of Ziebol discloses all the claimed subject matter as
`
`required. The Fig. 5 in Mermet shows that wherein the skirt 52 has a length that is greater than the height
`
`of the thread a-d (shownin the marked-up figure above).
`
`Regarding claim 12, Mermetin view of Ziebol discloses all the claimed subject matter as
`
`required. Mermetdiscloses that wherein: a terminal/top end surface of the male post 12 facing the
`
`opening has an aperture 20; and at least a portion of the male post 12 is hollow, see Fig. 5.
`
`Regarding claim 13, Mermetin view of Ziebol discloses all the claimed subject matter as
`
`required. Mermetdiscloses that wherein the male post 12 comprises a taper with a diameter near the
`
`bottom (near elements 23-24) that is larger than a diameter near the opening (near elements 10-11), see
`
`Fig. 5.
`
`Regarding claim 14, Mermetdiscloses a cap 2 for removable attachment to an open female luer
`
`device 3, in Figs. 1-6, the cap 2 comprising:
`
`a body 10 comprising an opening (at 10 or 11 in Fig. 5), a bottom 13 (Fig. 2), and a chamber (an
`
`interior space of the wall 11) defined between the opening 10/11 and the bottom 13;
`
`a wall 11 of the chamber comprising a thread a-d (see marked-up figure below) originating
`
`proximate the opening and extending into the chamber, wherein the male post 12 is spaced from the wall
`
`11 and at least a portion of the thread a-d having a height that increases as a function of increasing
`
`distance from the opening;
`
`a male post 12 in the chamber projecting from the bottom 13 towards the opening of the body;
`
`wherein the male post 12 is space from the wall 11;
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 10
`
`a movable piston 4 comprising: a central opening (an interior space of the stud 50) surrounding
`
`the male post 12, see Fig. 6; a top region (upper surface of the stud 50) extending from the central
`
`opening and comprising a sealing surface (an inner surface of the stuff 50 and surface 51), see Fig. 6
`
`a flexible circumferential skirt 52 extending laterally from the movable piston 4 at an acute angle a (less
`
`than 90 degrees), see marked up figure below; wherein the skirt is a flange 51/52 with a gap 55 between
`
`the flange and the top region, wherein the flange is in slidable contact (at close to bottom region of the
`
`wall 11, around location near element 23-24 in Fig. 5) with the wall 11 of the chamber
`
` No
`aEBSeS
`“Gee
`Dregeas
`u~ NS.
`5d
`
`i
`
`PaLL
`
`‘,
`
`Say SSS SSE A SES,
`
`_
`
`Ty
`
`be
`
`Mermetdoes not disclosealiquid disinfectant in the chamber between the bottom of the body
`
`and the movable piston.
`
`Ziebol discloses a cap 120 in Figs. 17-22 comprising: a body comprising an opening 192 (Fig. 17)
`
`and bottom (opposite side of the opening 192); a chamber 194; a male post located inside the chamber
`
`194, see similar figure 21; a liquid disinfectant 191 contains antimicrobial residue 291 in the chamber 194
`
`between the bottom of the body and the opening, see Figs. 17-22.
`
`It would have been obvious to one of ordinary skill in the art, prior to the effectivefilling date of the
`
`claimed invention to modify the device of Mermet with providing a liquid disinfectant in the chamber, as
`
`taught by Ziebol, in order to kill a broad spectrum of organisms, col. 23, lines 16-18
`
`Thus, Mermetin view of Ziebol disclosesthat a liquid disinfectant (as modified by Ziebol)
`
`located inside the chamber 11 of the cap 2. In other words, the liquid disinfectant is in the chamber
`
`between the bottom 13/24 of the body and the movable piston 4. Note: Ziebol also discloses that with the
`
`passin of time lock solution 191 can evaporate leaving antimicrobial residue 291 inside the chamber, col
`
`
`
`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 11
`
`22, lines 35-38, also see col. 23, lines 12-18. Therefore, when the movable piston 4 positioned on the
`
`male post 12, the flange 52/55 of the skirt 52 is in slidable contact with the wall of the chamber 11 (at the
`
`bottom wall of the chamber 11, or at a valley 24 in the chamber 11, see Figs. 5-6 in Mermet.
`
`Regarding claim 15, Mermetin view of Ziebol discloses all the claimed subject matter as
`
`required. Mermet showsin the marked-up figure below that an engagement mechanism comprising a
`
`thread, wherein a least a portion of the thread a-d having a height that increases as a function of
`
`increasing distance from the opening.
`
`Regarding claim 16, Mermetdisclosesa disinfecting system, in Figs. 5-6 comprising:
`
`an open female luer device 3 having a lumen (a passage receives the element4, in Fig. 6) and
`
`an open distal end 30 with a contacting surface (an inner surface of the passage) surrounding the lumen;
`
`a cap 2 comprising: a body 10 comprising an opening (at 10 or 11 in Fig. 5), a bottom 13 (Fig. 2),
`
`and a chamber (aninterior space of the wall 11) defined between the opening 10/11 and the bottom 13;
`
`a wall 11 of the chamber comprising a thread a-d (see marked-up figure below) originating
`
`proximate the opening and extending into the chamber, wherein the male post 12 is spaced from the wall
`
`11 and at least a portion of the thread a-d having a height that increases as a function of increasing
`
`distance from the opening;
`
`a male post 12 in the chamber projecting from the bottom 13 towards the opening of the body;
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`wherein the male post 12 is space from the wall 11;
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`
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`Application/Control Number: 17/088,756
`Art Unit: 3783
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`Page 12
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`a movable piston 4 positioned about the male post 12; wherein the contacting surface of the open
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`female luer engages with a sealing surface of the moveable piston (e.g. the sealing surface is an outer
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`surface of the stud 50 being contact the inner surface of the passage of the female luer device, see Fig.
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`6.
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`Mermetdoes not discloses that a liquid disinfectant in the chamber between the bottom of the
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`body and the movable piston;
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`Ziebol discloses a cap 120 in Figs. 17-22 comprising: a body comprising an opening 192 (Fig. 17)
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`and bottom (opposite side of the opening 192); a chamber 194; a male post located inside the chamber
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`194, see similar figure 21; a liquid disinfectant 191 contains antimicrobial residue 291 in the chamber 194
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`between the bottom of the body and the opening, see Figs. 17-22.
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`It would have been obvious to one of ordinary skill in the art, prior to the effectivefilling date of the
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`claimed invention to modify the device of Mermet with providing a liquid disinfectant in the chamber, as
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`taught by Ziebol, in order to kill a broad spectrum of organisms, col. 23, lines 16-18.
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`Thus, Mermetin view of Ziebol discloses thata liquid disinfectant (as modified by Ziebol) is
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`located inside the chamber 11 of the cap 2. In other words, the liquid disinfectant is in the chamber
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`between the bottom 13/24 of the body and the movable piston 4.
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`Regarding claim 17, Mermetin view of Ziebol discloses all the claimed subject matter as
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`required. Mermetfurther discloses that the movable piston 4 comprises: a central opening (an interior
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`space of the stud 50) with an interferencefit, i.e. an inner surface of the stud 50, surrounding the male
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`post 4;
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`a top region extending from the central opening and comprising a sealing surface. i.e. inner
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`and/or outer surface of the stud 50; and
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`a flexible circumferential skirt 52 in slidable contact with the wall of the chamber (at the bottom 24
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`wall of the chamber, seeFig. 6).
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`Claims 1-4, 6-7, 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Korogi
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`et al. (US 7,559,530) in view of Mermet (US 2004/0261872) and Howlett et al. (US 2009/0062766).
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`
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`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 13
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`Regarding claim 1-4, 6, Korogi discloses a cap, in Figs. 13-15 configured for removable
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`attachment a medical device 79.
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`Korogi discloses the cap comprising:
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`a body 93 & 89 comprising an opening (at distal opening in a part of the housing 93), a bottom
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`(base element 91), and a chamber (an interior space of the housing 93) defined between the opening and
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`the bottom;
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`a male post 99 in the chamber and projecting from the bottom towards the opening of the body;
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`a wall 93 of the chamber comprising a thread 95 originating proximate the opening and extending
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`into the chamber, wherein the male post 99 is spaced from the wall 93;
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`a movable piston 55 positioned about the male post 99.
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`Korogi does notdisclose that: the thread having a height that increases as a function of
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`increasing distance from the opening; andaliquid disinfectant in the chamber between the bottom of the
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`body and the movable piston.
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`Mermetdiscloses a cap 2 configured for removable attachment to an open female luer device 3
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`comprising: a body 11 comprising: an opening (e.g. defined at a distal end of a wall 11); a wall 11 ofa
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`chamber(an interior space of a wall 11) comprising: a thread 11 originating proximate the opening and
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`extending into the chamber; at least a portion of the thread having a height that increases as a function of
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`increasing distance from the opening.
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`
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`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 14
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`It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the
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`claimed invention to modify the device of Korogi with a thread in the chamber having a height that
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`increases as a function of increasing distance from an opening at a cap, as taught by Mermet, in order to
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`enhance of connection in between the cap and the female Iuer device and also to allow the cap being
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`connected with different size of the female connector device.
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`Howlett discloses a cap 302 in Figs. 19-20 comprising: a body 302 comprising an opening 304; a
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`liquid disinfectant 160 (a pad 160 contains an antiseptic agent, paras [0073-0074, 0091]) in the chamber
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`and around a male post 308.
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`It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the
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`claimed invention to modify the device of Korogi with providing a liquid disinfectant at the bottom of the
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`chamberor a liquid disinfectant in the chamber, as taught by Howlett, in order to cleanse and disinfect the
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`medical connector.
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`Korogi in view of Mermet(or Korogi in view of Mermet and Howlett) comprising: a liquid
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`disinfection 160 (as modified by Howlett) is located at/on a bottom/base of the housing in the chamber
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`and the pad 160 is located in between the bottom of the body and the movable piston.
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`
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`Application/Control Number: 17/088,756
`Art Unit: 3783
`
`Page 15
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`Regarding claim 2, wherein the movable piston 55 comprises: a central opening with an
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`interferencefit surrounding the male post 99; a top region extending from the central opening and
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`comprising a sealing surface; and a flexible circumferential skirt in slidable contact with the wall of the
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`chamber, see Figs. 13-15.
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`Regarding claim 3, the Fig. 13 showsthat a plurality of ribs 53 positioned about a periphery of
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`the bottom region; however, a person skilled in the art would recognize that the ribs can be positioned
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`about periphery of the top region, (e.g. the ridges 15 located about a periphery of the top region, in Figs.
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`1, 4 & 8), as considered as rearrangementparts, please see the marked-up figure abovein the rejection
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`of claim 1.
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`Regarding claim 4, the Fig. 13 showsthat a plurality of ribs 53 positioned about a periphery of
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`the bottom region; however, a person skilled in the art would recognize that the ribs can be positioned
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`about periphery of the top region, (e.g. the ridges 15 located about a periphery of the top region, in Figs.
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`1, 4 & 8), as considered as rearrangementparts. Therefore, each of the ribs 53 has a contact surface
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`area where eachrib contacts the top region of the movable piston (as rearrangement parts); and a
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`cumulative contact surface area of the ribs 53 for all of the ribs (in this case, two ribs 53) is less than
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`about 50%ofa total surface area of the top region, please see the marked-up figure abovein the
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`rejection of claim 1.
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`. Regarding claim 6, Korogi in view of Mermet and Howlett disclosesall the claimed subject
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`matter as required. Mermetdiscloses in the marked-up figure above that wherein: the thread comprises a
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`first portion (a) and a secondportion (b or c or d); the first portion is closer to the opening than the
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`second portion. It appears in the marked-up figure above that the second portion has a heightthatis at
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`least about 50%higher than the first portion.
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`In addition, it would have been obvious to one having
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`ordinary skill in the art at the time of the invention was made to obtain a second thread being at least
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`50%-150%higher than the first portion t