www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/260,616
`
`01/15/2021
`
`Petra L. Kohler Riedi
`
`80508US006
`
`7883
`
`3M INNOVATIVE PROPERTIES COMPANY
`PO BOX 33427
`ST. PAUL, MN 55133-3427
`
`BROWN,SETH RICHARD
`
`ART UNIT
`
`3786
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/05/2023
`
`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)
`
`

`

`
`
`Disposition of Claims*
`1-20 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) 16-20 is/are withdrawn from consideration.
`[) Claim(s)__ is/are allowed.
`Claim(s) 1-15 is/are rejected.
`S)
`) © Claim(s)____is/are objected to.
`C] 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) The drawing(s)filed on 15 January 2021 is/are: a) accepted or b)C] 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)0) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)() None ofthe:
`b)( Some**
`a)C) All
`1.2 Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have beenreceived in Application No.
`3.2.) 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 22 April 2021 & 27 October 2021.
`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 20230913
`
`Application No.
`Applicant(s)
`17/260,616
`Kohler Riedi et al.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`Seth R Brown
`3786
`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 17 July 2023.
`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.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 2
`
`DETAILED ACTION
`
`This is the initial Office action for non-provisional application 17/260,616 filed 15 January
`
`2021 which claims domestic benefit from provisional application 62/712,039 filed 30 July 2018.
`
`Claims 1-20 are currently pending.
`
`Notice of Pre-AlA or AIA Status
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined underthe
`
`first inventor to file provisions of the AIA.
`
`Election/Restrictions
`
`2.
`
`Applicant's election with traverse of Group | in the reply filed on 17 July 2023 is
`
`acknowledged. The traversal is on the groundsthat the scope of analysis of novelty of all the
`
`claims of Groups | and II would haveto be as rigorous as whenonly the claims of Group | were
`
`being separately and that this duplication of effort would not be warranted where theseclaims of
`
`different subclasses are so interrelated. Further, Applicants submit that restriction between the
`
`claims in Groups| and II would place an undue burden on Applicants by requiring separatefiling
`
`fees for examination of the nonelected claims, as well as the added costs associated with
`
`prosecuting two applications and maintaining two patents. This is not found persuasive because
`
`the establishment of burden on the Office applies to US casesonly. The instant application is a
`
`national stage entry of an international application under 35 U.S.C. 371. As a result, lack of
`
`unity practice is observedfor restriction purposes. Additionally, the burden offiling fees is not a
`
`proper means oftraversal.
`
`The requirementis still deemed proper and is therefore made FINAL.
`
`Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as
`
`being drawn to a nonelected invention, there being no allowable generic or linking claim.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 3
`
`Applicant timely traversed the restriction (election) requirementin the reply filed on 17 July
`
`2023.
`
`Claim Objections
`
`1.
`
`Claim 1
`
`is objected to becauseofthe following informalities: the recitation of “a first
`
`major surface and a second major surface”in line 6 should be amendedto clarify that these
`
`major surfacesdiffer from the major surfaces recited in line 2. The same terms should not be
`
`used for different parts. Appropriate correction is required for each use of the term.
`
`2.
`
`Claims 4, 6-7 and 10-11 are objected to for the same reason as claim 1 above. The
`
`same terms should not be usedfor different parts. Appropriate correction is required for each
`
`use of the term, “first major surface” or “second major surface” when referring to the article.
`
`3.
`
`Claim 3 is objected to becauseofthe following informalities: the recitation "wherein
`
`discrete domains"in line 1 is lacking the word “the” prior to discrete domains to indicate that
`
`these are the same discrete domains as previously claimed. This objection may be overcome
`
`with language such as “wherein the discrete domains’.
`
`4.
`
`Claim 6 is objected to because of the following informalities: the recitation “surfaces of
`
`discrete domains’in lines 1-2 is lacking the word “the” prior to discrete domainsto indicate that
`
`these are the same discrete domains as previously claimed. This objection may be overcome
`
`with language such as “surfaces of the discrete domains”.
`
`5.
`
`Claim 14 is objected to because of the following informalities: the terms “antioxidants”,
`
`“silver sulphadiazine’”, “fusidic acid” and “pirfenedine” appeartwice in the grouping. Appropriate
`
`correction is required.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 4
`
`Claim Rejections - 35 USC § 112(b)
`
`The following is a quotation of 35 U.S.C. 112(b):
`(bo) 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 moreclaims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`6.
`
`Claims 8-10 are rejected under 35 U.S.C. 112(b6) 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 which the inventor or a joint inventor (or for applications subject to pre-AlA 35 U.S.C.
`
`112, the applicant), regards as the invention.
`
`a.
`
`Claim 8 recites the limitation “additional discrete domains”in line 1. It is unclear what
`
`constitutes an additional discrete domain as there is already an undefined plurality of discrete
`
`domains recited in claim 1. This rejection may be overcome by defining the numberof discrete
`
`domains in claim 1 or by describing the location of the discrete domains such that the discrete
`
`domains and additional discrete domains are different.
`
`b.
`
`Claim 10 recites the limitation “surfaces of additional discrete domains”in line 2. It is
`
`unclearif these additional discrete domains are the same as the additional discrete domains in
`
`claim 8. This rejection may be overcome with language suchas “surfacesof the additional
`
`discrete domains’.
`
`Cc.
`
`Claim 9 is rejected for depending from claim 8 and not remedying the deficiencies of
`
`claim 8.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 5
`
`Claim Rejections - 35 USC § 112(d)
`
`The following is a quotation of 35 U.S.C. 112(d):
`
`(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent
`form shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependent form shall be construed to
`incorporate by referenceall the limitations of the claim to whichit refers.
`
`The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
`
`Subject to the following paragraph[i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim
`in dependent form shall contain a reference to a claim previously set forth and then specify a
`further limitation of the subject matter claimed. A claim in dependent form shall be construed
`to incorporate by referenceall the limitations of the claim to whichit refers.
`
`7.
`
`Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AlA 35 U.S.C. 112, 4th paragraph, as
`
`being of improper dependentform for failing to further limit the subject matter of the claim upon
`
`which it depends, orfor failing to include all the limitations of the claim upon which it depends. In
`
`the instant application, claim 1 already recites an undefined plurality of discrete domains so the
`
`addition of additional domains is notfurther limiting. Applicant may cancel the claims, amend the
`
`claims to place the claims in proper dependentform, rewrite the claims in independent form, or
`
`present a sufficient showing that the dependent claims complies with the statutory requirements.
`
`This rejection may be overcome by defining the number of discrete domains in claim 1 or by
`
`describing the location of the discrete domains such that the discrete domains and additional
`
`discrete domains aredifferent.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
`
`basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
`on sale, or otherwise available to the public before the effectivefiling date of the claimed
`invention.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 6
`
`(a)(2) the claimed invention was described in a patent issued under section 151, or in an
`application for patent published or deemed published under section 122(b), in which the
`patent or application, as the case may be, namesanother inventor and waseffectively filed
`before the effective filing date of the claimed invention.
`
`8.
`
`Claims 1-2 and 7-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
`
`US 2003/0149406 (Martineau et al.).
`
`a.
`
`Regarding claim 1, Martineau discloses an article ([Abstract], “A medicated multi-
`
`layered polyurethane foam dressing and drug delivery device”), comprising:
`
`a polymer foam ([0010], “The dressing comprises one layer of hydrophilic polyurethane
`
`foam, preferably HYPOL™polyurethane”) having a first major surface and a second major
`
`surface (Figure 2B showsthat the polymer foam hasa first major surface and a second major
`
`surface. See the annotated figure below);
`
`and discrete domains of a therapeutic composition ([0047], “Referring to FIGS. 2A and
`
`2B, a dressing 20, being a second embodimentof the present invention, has a drug-reservoir
`
`layer 12 comprised of a hydrophilic polyurethane foam layer, being illustrated as having two
`
`drugs 14, 16 in dispersed relation therein’; the drug-reservoirs are analogous to discrete
`
`domains and the drugs are analogous to therapeutic compositions. See the annotated figure
`
`below.) at least partially surrounded by the polymer foam ([0047], “has a drug-reservoir layer 12
`
`comprised of a hydrophilic polyurethane foam layer”);
`
`wherein an exterior surface of each discrete domain substantially conforms to a portion
`
`of the first major surface of the polymer foam (Figure 2B showsthat an exterior surface of the
`
`discrete domains substantially conforms to a portion of the first major surface. This
`
`interpretation is due to the broadnessof the term “substantially conforms”. The analogous
`
`discrete domains are being interpreted to substantially conform to the first major surface
`
`because conforming is to give the same shape, outline, or contour. In the instant case, the
`
`analogous discrete domains outline the first major surface.);
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 7
`
`wherein the article comprisesa first major surface and a second major surface (Figure
`
`2B showsthat the article has a first major surface and a second major surface. See the
`
`annotated figure below.);
`
`and wherein a portion of the first major surface of the polymer foam and the exterior
`
`surfaces of discrete domains form the first major surface of the article (Figure 2B showsthat the
`
`first major surface of the polymer foam andthe exterior surfaces of discrete domains form the
`
`first major surface of the article.).
`
`Fig. 24
`
`
`
`Fig. 2B
`
`Annotated Figure 2B of Martineau
`
`b.
`
`Regarding claim 2, Martineau discloses the article of claim 1, wherein the article is a
`
`wound dressing ([Abstract], “A medicated multi-layered polyurethane foam dressing and drug
`
`delivery device”).
`
`Cc.
`
`Regarding claim 7, Martineau discloses the article of claim 1, further comprising a liner
`
`on top of or adjacentto the first major surface of the article ({0048], “The two adhesive under-
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 8
`
`surfaces of the layer 34 and the hydrogel layer 17 are each protected by a respective cover
`
`sheet 18”; a cover sheet 18 is analogoustoaliner).
`
`d.
`
`Regarding claim 8, Martineau discloses the article of claim 1, further comprising
`
`additional discrete domains of the therapeutic composition at least partially surrounded by the
`
`polymer foam ([0047], “Referring to FIGS. 2A and 2B, a dressing 20, being a second
`
`embodiment of the present invention, has a drug-reservoir layer 12 comprised of a hydrophilic
`
`polyurethane foamlayer, being illustrated as having two drugs 14, 16 in dispersed relation
`
`therein”; additional drug reservoirs are disposed at least partially surrounded by the polymer
`
`foam).
`
`e.
`
`Regarding claim 9, Martineau disclosesthe article of claim 8, wherein the exterior
`
`surface of each additional discrete domain substantially conforms to a portion of the second
`
`major surface of the polymer foam (Figure 2B showsthat an exterior surface of the discrete
`
`domains substantially conforms to a portion of the second major surface. This interpretation is
`
`dueto the broadnessof the term “substantially conforms”. The analogous discrete domains are
`
`being interpreted to substantially conform to the second major surface because conforming is to
`
`give the same shape, outline, or contour. In the instant case, the analogous discrete domains
`
`outline the second major surface.).
`
`f.
`
`Regarding claim 10, Martineau discloses the article of claim 8, wherein a portion of the
`
`second major surface of the polymer foam and the exterior surfaces of additional discrete
`
`domains form the second major surface of the article (Figure 2B showsthat the second major
`
`surface of the polymer foam and the exterior surfaces of discrete domains form the second
`
`major surface of the article.).
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 9
`
`g-
`
`Regarding claim 11, Martineau discloses the article of claim 1, further comprising a
`
`second liner on top of or adjacent to the second major surfaceof the article ([0048], “The two
`
`adhesive under-surfacesof the layer 34 and the hydrogel layer 17 are each protected by a
`
`respective cover sheet 18”; a cover sheet 18 is analogous toaliner).
`
`h.
`
`Regarding claim 12, Martineau discloses the article of claim 1, wherein the polymer
`
`foam comprises materials selected from the group consisting of polyurethane, polyvinylacetate,
`
`polyvinylalcohol, polyethylene, and silicone ([0010], “The dressing comprises onelayer of
`
`hydrophilic polyurethane foam, preferably HYPOL™ polyurethane, and at least one surface-
`
`contacting layer of hydrogel, preferably HYPOL hydrogel. The hydrophilic layer functions as a
`
`drug reservoir capable of absorbing the excess exudate”).
`
`i.
`
`Regarding claim 13, Martineau discloses the article of claim 1, wherein the therapeutic
`
`composition is retained in the discrete domains ([0047], “Referring to FIGS. 2A and 2B, a
`
`dressing 20, being a second embodiment of the present invention, has a drug-reservoir layer 12
`
`comprised of a hydrophilic polyurethane foam layer, being illustrated as having two drugs 14, 16
`
`in dispersed relation therein’).
`
`j-
`
`Regarding claim 14, Martineau discloses the article of claim 1, wherein the therapeutic
`
`composition comprises an active agent selected from the group consisting of antimicrobial
`
`agents, antibiotics, antioxidants, platelet-derived growth factor, vitamin A, vitamin C, vitamin E,
`
`corticosteroids, silver sulphadiazine, polymixin B sulphate, fusidic acids, pirfenedine, interferon,
`
`therapeutic oils, plant extracts, animal extracts, pharmaceutical, vitamins, hormones,
`
`antioxidants, emu oil, aloe vera, lavenderoil, rosehip oil, silver sulphadiazine, polymyxin B,
`
`fusidic acid and pirfenedine.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 10
`
`k.
`
`Regarding claim 15, Martineau discloses the article of claim 1, wherein the therapeutic
`
`composition comprises an antimicrobial agent ([0056], “The drug delivery dressing may contain
`
`a drug or combination thereof selected from a group including but notlimited to: broad spectrum
`
`antibiotics, antimicrobials, antifingals, antipathogenic peptides, antiseptics, hemostatic agents,
`
`local analgesics, central nervous acting agents, wound healing agents (e.g., growth factors),
`
`immunosuppressives, and all safe drugs that can be delivered to human tissues’).
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
`
`rejections set forth 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 and the prior art are such that the claimed invention as a whole would have
`been obvious beforethe effectivefiling 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.
`
`9.
`
`Claim 1 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over
`
`US 2003/0072792 (Flanigan etal.) in view of US 2003/0149406 (Martineau et al.). This
`
`rejection does not replace the rejection above andis in addition to the rejection above.
`
`a.
`
`Regarding claim 1, Flanigan discloses an article ([Abstract], “A transdermal delivery
`
`device”; the embodiments are all analogous articles and the teachings of one embodimentwill
`
`be applied to the other embodiments), comprising:
`
`a first major surface and a second major surface (Fig. 5a; the first major surface 220; the
`
`second major surface 230);
`
`and discrete domains of a therapeutic composition (a plurality of reservoirs 240; [0012],
`
`“wherein the first adhesive layer comprises at least onefirst array of reservoirs, and wherein the
`
`first array of reservoirsis at least partially filled with one of air andafirst medicinal ingredient’:
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 11
`
`the reservoirs are analogous to discrete domains and the medicinal ingredient is analogous to a
`
`therapeutic composition);
`
`wherein an exterior surface of each discrete domain substantially conforms to a portion
`
`of the first major surface ([0007], “If an overlayer is placed in contact with a surface of a
`
`structured layer having a surface topography, certain regions of the structured layer become
`
`discrete or discontinuous channels or reservoirs that may be used to advantage to tailor the
`
`properties of the laminate construction”; Fig. 5a shows that the analogous discrete domains
`
`conform to a portion of the first major surface);
`
`wherein the article comprisesafirst major surface and a second major surface (Fig. 5a
`
`showsa first and second major surfaceof the article; see the annotated figure below);
`
`and wherein a portion of the first major surface and the exterior surfaces of discrete
`
`domains form the first major surface of the article (Fig. 5a shows that a portion of the first major
`
`surface and the exterior surfaces of discrete domains form the first major surface ofthe article).
`
`
`
`Annotated Figure 5A of Flanigan
`
`Flanigan does not disclose wherein the article comprises a polymer foam.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 12
`
`However, Martineau discloses an article comprising a polymer foam (Martineau: [0010],
`
`“The dressing comprises one layer of hydrophilic polyurethane foam, preferably HYPOL™
`
`polyurethane, and at least one surface-contacting layer of hydrogel, preferably HYPOL
`
`hydrogel. The hydrophilic layer functions as a drug reservoir capable of absorbing the excess
`
`exudate”).
`
`It would have been obvious to an artisan of ordinary skill before the effective filing date
`
`to make the adhesivelayer of Flanigan of a polymer foam as taught by Martineau. A skilled
`
`artisan would have been motivated to do so because Martineau teachesthat the polymer foam
`
`can form a drug reservoir and is capable of absorbing excess exudate (Martineau: [0010]). A
`
`skilled artisan would have a reasonable expectation of successgiven that all references are
`
`analogous and drawn to wound dressings comprising drug reservoirs.
`
`As a result of the combination, wherein the adhesive layer of Flanigan is made of a
`
`polymer foam, the discrete domains of a therapeutic composition are at least partially
`
`surrounded by the polymer foam, an exterior surface of each discrete domain substantially
`
`conforms to a portion of the first major surface of the polymer foam, and a portion ofthe first
`
`major surface of the polymer foam and the exterior surfaces of discrete domains form the first
`
`major surfaceof the article.
`
`10.
`
`Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over US
`
`2003/0072792 (Flanigan etal.) in view of US 2003/0149406 (Martineau etal.).
`
`a.
`
`Regarding claim 3, Flanigan discloses the article of claim 1, wherein the discrete
`
`domains form a pattern ([0035], “The structured topographyincludes structures 114 with specific
`
`shapesthat form a plurality of discrete reservoirs or channels 140 when overlain by the cap
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 13
`
`layer 100. Preferably, the structures form a substantially regular array or pattern in the adhesive
`
`layer and include, for example, rectilinear patterns, polar patterns, geometric patterns, and
`
`cross-hatch patterns”).
`
`b.
`
`Regarding claim 4, Flanigan discloses the article of claim 1, wherein at least at one
`
`plane that is parallel to the first major surface of the article and between the first and the second
`
`major surface of the article, the cross section of each discrete domain is greater than the cross
`
`section of the exterior surface of the discrete domain ([0036], “The design and position of the
`
`structures(i.e., pitch, depth, size, contact area, wall and post width, and shape) can be
`
`controlled to achieve precise placementof reservoirs of specific sizes and shapes”).
`
`It would have been an obvious matter of design choice to make the crosssection of
`
`each discrete domain greater than the cross section of the exterior surface of the discrete
`
`domain, since such a modification would have involved a mere change in shape of a
`
`component. A change in shapethat is absent of persuasive evidencethat the particular
`
`configuration of the claimed componentis significant is recognized as being within the level of
`
`ordinary skill in the art before the filing date of the claimed invention. In re Dailey, 357 F.2d 669,
`
`149 USPQ 47 (CCPA 1966).
`
`c.
`
`Regarding claim 5, Flanigan discloses the article of claim 1, wherein the diameterof
`
`discrete domains is at least about 100 microns ([0050], “The distance W3 between the bases of
`
`the sidewalls 154 is preferably less than about 30 mm, morepreferably less than about 5 mm,
`
`mostpreferably about 50 um to about 250 um, as measured between anytwoparallel sidewalls
`
`154 of the reservoir or channel 152 (see also FIG. 4)”).
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 14
`
`d.
`
`Regarding claim 6, Flanigan discloses the article of claim 1, wherein the exterior
`
`surfaces of discrete domains cover between 1% and 99% ofthe first major surface of the article
`
`([0053], “The contact area betweenthe structures 114 on the first major surface 120 and the
`
`cap layer 100 may vary widely depending on the intended application, and is between about
`
`0.5% and about 99%; preferably between about 5% to about 80%; and morepreferably
`
`between about 20%to about 40%”; the exterior surfaces of the discrete domainsis the inverse
`
`of the structures 114 and therefore may cover between 99.5% and about 1%).
`
`In the case wherethe claimed ranges "overlapor lie inside ranges disclosed by the prior
`
`art" a prima facie case of obviousness exists. It would have been obvious to one having
`
`ordinary skill in the art before the effective filing date of the claimed invention for the exterior
`
`surfacesof the discrete domains to cover between 1% and 99% ofthe first major surface of the
`
`article, since it has been held that where the general conditions of a claim are disclosed in the
`
`prior art, discovering the optimum or workable rangesinvolves only routine skill in the art. See
`
`MPEP 2144.05.
`
`Conclusion
`
`The following prior art made of record and not relied upon are considered pertinent to
`
`applicant's disclosure.
`
`US 2014/0065202 (Ito) discloses a composite film comprising discrete domains and a
`
`drug-releaselayer.
`
`US 2008/0020007 (Zang) disclosesa liquid-containing film structure comprising discrete
`
`domains for a transdermal delivery system.
`
`US 2016/0082148(Ito et al.) discloses a film comprising discrete domains madeof a
`
`biodegradable polymer.
`
`

`

`Application/Control Number: 17/260,616
`Art Unit: 3786
`
`Page 15
`
`US 9,327,105 (Ramdaset al.) discloses an active transdermal drug delivery system
`
`comprising discrete domains.
`
`US 6,207,181 (Herrmann) discloses a reservoir for controlled active substance delivery
`
`comprising a discrete domain in a plurality of configurations.
`
`Anyinquiry concerning this communication or earlier communications from the examiner
`
`should be directed to Seth Brown whosetelephone numberis (571)272-5642. The examiner
`
`can normally be reached 8:00 AM — 11:00 AM or 1:00 PM — 3:00 PM ET.
`
`Examiner interviews are available via telephone, in-person, and video conferencing
`
`using a USPTO supplied web-basedcollaboration tool. To schedule an interview, applicant is
`
`encouraged to use the USPTO AutomatedInterview Request(AIR) at
`
`http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’ s
`
`supervisor, Rachael Bredefeld can be reachedat (571)270-5237. The fax phone numberfor the
`
`organization wherethis application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be
`
`obtained from Patent Center. Unpublished application information in Patent Centeris available
`
`to registered users. To file and manage patent submissions in Patent Center, visit:
`
`https://patentcenter.uspto.gov. Visit https:/;www.uspto.gov/patents/apply/patent-center for more
`
`information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about
`
`filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC)at
`
`866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service
`
`Representative, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/SETH R. BROWN/
`Examiner, Art Unit 3786
`
`/RACHAEL E BREDEFELD/
`Supervisory Patent Examiner, Art Unit 3786
`
`