UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
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`w
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`'I AND1%9
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`15/159,457
`
`05/19/2016
`
`Dorothy Joanis
`
`ISA—134.02
`
`7309
`
`08/21/2017 —FOLEY HOAG, LLP (wnsm m
`
`7590
`63767
`
`
`GRASER, JENN ‘ERE
`PATENT GROUP, Seaport West
`155 SEAPORT BLVD
`BOSTON, MA 02210-2600
`
`PAPER NUMBER
`
`1645
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`08/21/2017
`
`ELECTRONIC
`
`Please find below and/0r attached an Office communication concerning this application or proceeding.
`
`The time 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):
`
`Patent @ foleyhoag.com
`pair_foleyhoag@firsttofile.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 15/159,457 JOANIS ET AL.
`
`
`AIA (First Inventor to File)
`Art Unit
`Examiner
`Office Action Summary
`
`
`JENNIFER GRASER [SENS 1645
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1.136(a).
`after SIX (6) MONTHS from 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) MONTHS from 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, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1 .704(b).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)|:I Responsive to communication(s) filed on
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|Z| This action is non-final.
`2a)|:I This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:| 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 Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI C|aim(s) M is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6 El Claim s)
`s M is/are rejected.
`
`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) I] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mai| Date .
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20170816
`
`) )
`
`_
`
`
`is/are objected to.
`
`are subject to restriction and/or election requirement.
`9)I:I C|aim(s
`)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`
`
`
`hit
`:i/wwwusnto. ov/ atentS/init events/
`iindex.‘s orsend an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 5/19/16 is/are: a)IZI accepted or b)I:I 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)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`3.|:| Copies of the certified copies of the priority documents have been received in 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)
`
`
`
`

`

`Application/Control Number: 15/159,457
`
`Page 2
`
`Art Unit: 1645
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`DETAILED ACTION
`
`Claims 10-14 are currently pending.
`
`Claim Rejections - 35 USC § 1 12-written description
`
`1.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`IN GEN ERAL.—The specification shall contain a written description of the
`(a)
`invention, and of the manner and process of making and using it, in such full, clear, concise,
`and exact terms as to enable any person skilled in the art to which it pertains, or with which it
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor orjoint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the
`manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it 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.
`
`2.
`
`Claims 13 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-
`
`AIA), first paragraph, as failing to comply with the written description requirement. The
`
`claim(s) contains subject matter which was not described in the specification in such a
`
`way as to reasonably convey to one skilled in the relevant art that the inventor or a joint
`
`inventor, or for pre-AIA the inventor(s), at the time the application was filed, had
`
`possession of the claimed invention.
`
`Claims 13 and 14 contain new matter which was not recited in the original claims
`
`or original specification. The term “hinged test card” was not found. Applicants should
`
`remove the new matter from the claims or point to written support for such term by page
`
`and line number.
`
`

`

`Application/Control Number: 15/159,457
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`Page 3
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`Art Unit: 1645
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`Claim Rejections - 35 usc § 1 12-2"d paragraph
`
`3.
`
`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-AIA), 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.
`
`4.
`
`Claims 10-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
`
`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 pre-AIA the
`
`applicant regards as the invention.
`
`Claims 10-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA),
`
`second paragraph, as being incomplete for omitting essential steps, such omission
`
`amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are:
`
`there is no correlation step which indicates what any of the detection/results mean.
`
`What if one assay has a positive result and one has a negative result? What if both
`
`assays are negative? Appropriate clarification and correction is required.
`
`Claim Rejections - 35 USC § 1 12-Enablement
`
`5.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`IN GEN ERAL.—The specification shall contain a written description of the
`(a)
`invention, and of the manner and process of making and using it, in such full, clear, concise,
`and exact terms as to enable any person skilled in the art to which it pertains, or with which it
`is most nearly connected, to make and use the same, and shall set forth the best mode
`contemplated by the inventor orjoint inventor of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`

`

`Application/Control Number: 15/159,457
`
`Page 4
`
`Art Unit: 1645
`
`The specification shall contain a written description of the invention, and of the
`manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it 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.
`
`6.
`
`Claims 10-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA),
`
`first paragraph, as failing to comply with the enablement requirement. The claim(s)
`
`contains subject matter which was not described in the specification in such a way as to
`
`enable one skilled in the art to which it pertains, or with which it is most nearly
`
`connected, to make and/or use the invention.
`
`The instant claims allow for the detection of any Staphylococcus aureus antigens
`
`in the first assay. This is incredibly broad description and the specification has only
`
`shown results with S. aureus protein A in one assay and PBP2a in the second assay.
`
`It
`
`would take undue experimentation for one skilled in the art to discover another antigen
`
`which would equally as well. Further, claims 10 and 12-14 are drawn to detecting any
`
`antibiotic resistance yet the specification has only shown and taught assays for
`
`detecting methicillin resistant S. aureus. Genentech Inc. v. Novo Nordisk A/S (CAFC)
`
`42 USPQZd 1001 clearly states: “Patent protection is granted in return for an enabling
`
`disclosure of an invention, not for vague intimations of general ideas that may or may
`
`not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696
`
`(1966) (stating, in context of the utility requirement, that "a patent is not a hunting
`
`license.
`
`It is not a reward for the search, but compensation for its successful
`
`conclusion") Tossing out the mere germ of an idea does not constitute enabling
`
`disclosure. While every aspect of a generic claim certainly need not have been carried
`
`

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`Application/Control Number: 15/159,457
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`Page 5
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`Art Unit: 1645
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`out by an inventor, or exemplified in the specification, reasonable detail must be
`
`provided in order to enable members of the public to understand and carry out the
`
`invention.”
`
`Factors to be considered in determining whether undue experimentation is
`
`required, are set forth in In re Wands 8 USPQ2d 1400. They include (1) the
`
`quantity of experimentation necessary, (2) the amount of direction or guidance
`
`presented, (3) the presence or absence of working examples, (4) the nature of the
`
`invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7)
`
`the predictability or unpredictability of the art and (8) the breadth of the claims.
`
`Applying the above test to the facts of record, it is determined that 1) no
`
`declaration under 37 C.F.R. 1.132 or other relevant evidence has been made of
`
`record establishing the amount of experimentation necessary, 2) insufficient
`
`direction or guidance is presented in the specification with respect to the use of proteins
`
`other than protein A and PBP2a and detecting antibiotic resistance other than
`
`methicillin-resistance, 3) the relative skill of those in the art is commonly recognized as
`
`quite high (post-doctoral level). With regard to (4) the nature of the invention and (5) the
`
`state of the prior art, these have been discussed above. One of skill in the art would
`
`require guidance, in order to make or use the methods as instantly claimed.
`
`Double Parenting
`
`7.
`
`The nonstatutory double patenting rejection is based on a judicially created
`
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`
`

`

`Application/Control Number: 15/159,457
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`Page 6
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`Art Unit: 1645
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`unjustified or improper timewise extension of the “right to exclude” granted by a patent
`
`and to prevent possible harassment by multiple assignees. A nonstatutory double
`
`patenting rejection is appropriate where the conflicting claims are not identical, but at
`
`least one examined application claim is not patentably distinct from the reference
`
`claim(s) because the examined application claim is either anticipated by, or would have
`
`been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
`
`USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
`
`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d)
`
`may be used to overcome an actual or provisional rejection based on nonstatutory
`
`double patenting provided the reference application or patent either is shown to be
`
`commonly owned with the examined application, or claims an invention made as a
`
`result of activities undertaken within the scope of a joint research agreement. See
`
`MPEP § 717.02 for applications subject to examination under the first inventor to file
`
`provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) -
`
`706.02(l)(3) for applications not subject to examination under the first inventor to file
`
`provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`1.321 (b).
`
`The USPTO Internet website contains terminal disclaimer forms which may be
`
`used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application
`
`

`

`Application/Control Number: 15/159,457
`
`Page 7
`
`Art Unit: 1645
`
`in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26,
`
`PTO/AlA/25, or PTO/AlA/26) should be used. A web-based eTerminal Disclaimer may
`
`be filled out completely online using web-screens. An eTerminal Disclaimer that meets
`
`all requirements is auto-processed and approved immediately upon submission. For
`
`more information about eTerminal Disclaimers, refer to
`
`www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
`
`8.
`
`Claims 10-14 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1-4 of U.S. Patent No. 9,372,191. Although the claims
`
`at issue are not identical, they are not patentably distinct from each other because the
`
`patented claims are a species of the broader claimed genus in the present application.
`
`The 'protein A' would be one of the S.aureus antigens detected and the instantly
`
`claimed method allows for any timeframe. Further, it is well-known in the art that
`
`antibody detection on a lateral flow device could be "visual". Accordingly, the patented
`
`claims and the instant claims are not patentably distinct.
`
`Claim Rejections - 35 USC § 103
`
`9.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis
`
`for all obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described
`as set forth in section 102, if the differences between the subject matter sought to be patented
`and the prior art are such that the subject matter as a whole would have been obvious at the
`time the invention was made to a person having ordinary skill in the art to which said subject
`matter pertains. Patentability shall not be negatived by the manner in which the invention was
`made.
`
`

`

`Application/Control Number: 15/159,457
`
`Page 8
`
`Art Unit: 1645
`
`10.
`
`Claims 10-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over Horii et al (US 2006/0051820 A1) in view of Lambert et al (US
`
`20050250141 A1) and Nakatomi et al (Microbiology and Immunology. 1998. 42: 739-
`
`742. "A rapid latex agglutination assay for the detection of penicillin-binding protein 2'") .
`
`Horii discloses a method, comprising: using a first immunoassay (abstract and
`
`para [0009]) to detect whether a particular gram positive bacteria is present in a sample
`
`from a gram positive blood culture (para [0009], detecting "protein A antigen in the
`
`blood, urine, sputum, spinal fluid, pleural effusion, ascites, pus, or other body fluid
`
`components from patients infected by S. aureus". Protein A is a marker for S. aureus
`
`infection. S. aureus is a gram positive bacteria).
`
`Lambert et al teach that lateral flow assays and devices were very well known in
`
`the prior art at the time the invention was made for a rapid test for antigens. Lambert et
`
`al specifically teaches the detection of S.aureus through dominant proteins. See
`
`specification at:
`
`[0002] Many Lateral Flow Assays (LFAs) are immunoassays that can be used to
`detect chemical or biological agents in various media including food, water, blood, urine,
`and saliva. The most commonly used LFA is the home pregnancy test which is
`performed frequently with minimal training or experience. The home pregnancy test is
`an example of an immunoassay designed to detect a single compound, human
`chorioni¢ gonadotropin, from a urine sample. LFAs are also commercially available for
`use in food and water safety, for detection of Escherichia coli, Salmonella, Legionella,
`etc.; food processing and food safety, for detection of food allergens such as peanuts,
`shellfish, etc.; clinical medicine, for detection of hCG, HIV, hepatitis C, etc.; and
`homeland defense (anthrax, botulinum toxin).
`
`

`

`Application/Control Number: 15/159,457
`
`Page 9
`
`Art Unit: 1645
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`A lateral flow test strip mounted within a hinged test card (claims 13 and 14-new
`
`limitation) would have been an obvious design choice which would not be expected to
`
`affect the outcome of the immunoassays.
`
`However, Horii and Lambert do not disclose the further claim limitation taught by
`
`Nakatomi, using a second immunoassay to detect the presence of a marker for
`
`antibiotic resistance (abstract, monoclonal antibodies raised against penicillin binding
`
`protein 2a (PBP2a) are used to conduct an agglutination reaction; PBP2a is a marker
`
`for antibiotic resistance).
`
`Nakatomi discloses using an immunoassay to detect the presence of a marker
`
`for antibiotic resistance (abstract), wherein the marker for antibiotic resistance is a
`
`penicillin binding protein (abstract; monoclonal antibodies raised against PBP2a).
`
`Nakatomi teaches an immunoassay to detect the presence of a marker for antibiotic
`
`resistance (abstract), wherein the particular antibiotic is methicillin (abstract; Nakatomi
`
`shows that anti-PBP2a antibodies specifically detects methicillin resistant
`
`Staphylococcus aureus. One skilled in the art will readily understand that this showing
`
`indicates that anti-PBP2a antibodies detect the particular antibiotic resistance marker,
`
`namely: methicillin.) Neither Horii nor Nakatomi disclose the further limitation which
`
`further comprises prior to step a, the step of obtaining a sample from a gram positive
`
`blood culture. However, it would have been obvious to one skilled in the art to modify
`
`the combination of Horii and Nakatomi to include a prior step of obtaining a sample for a
`
`gram positive blood culture as claimed, because it is more efficient to first determine
`
`

`

`Application/Control Number: 15/159,457
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`Page 10
`
`Art Unit: 1645
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`that a blood sample is infected with a gram positive bacteria before testing for the
`
`specific type of bacteria (Staphylococcus aureus) and the antibiotic resistance status.
`
`For example, if there is no gram positive bacterial infection, then there is no reason to
`
`test for a Staphylococcal infection. Horii discloses a method, comprising: detecting,
`
`using a first immunoassay, whether Staphylococcus aureus or another species of
`
`Staphylococcus is present in a sample from a gram positive blood culture (abstract,
`
`para [0009] Horii discloses detecting .Protein A antigen in the blood, urine, sputum,
`
`spinal fluid, pleural effusion, ascites, pus, or other body fluid components from patients
`
`infected by S. aureus.. Protein A is a specific marker for Staphylococcal infection and
`
`will detect Staphylococcus aureus or another Staphylococcus species.)
`
`It would have been obvious to one skilled in the art to combine the immunoassay
`
`of Horii detecting a particular gram positive bacteria present in a sample (the first
`
`immunoassay) with the monoclonal antibodies disclosed by Nakatomi to detect a
`
`marker of antibiotic resistance (PBP2a) as is claimed in this application, because doing
`
`so would increase efficiency by allowing quick determination of both
`
`bacterial species and antibiotic resistance at approximately the same time. Lambert
`
`teaches the use of lateral flow device is an obvious design choice for an immunoassay.
`
`Further it would have been obvious to one skilled in the art to use the anti-PBP2a
`
`monoclonal antibodies in a second immunoassay, since once a monoclonal antibody
`
`has been developed including it in an immunoassay is a procedure obvious to one
`
`skilled in the art because once a monoclonal antibody has been developed including it
`
`

`

`Application/Control Number: 15/159,457
`
`Page 11
`
`Art Unit: 1645
`
`in an immunoassay is a simple and straight forward procedure as one skilled in the art
`
`can understand.
`
`Lambert et al teach that lateral flow assays and devices were very well known in
`
`the prior art at the time the invention was made for a rapid test for antigens. Lambert et
`
`al specifically teaches the detection of S.aureus through dominant proteins. See
`
`specification at:
`
`[0002] Many Lateral Flow Assays (LFAs) are immunoassays that can be used to
`detect chemical or biological agents in various media including food, water, blood, urine,
`and saliva. The most commonly used LFA is the home pregnancy test which is
`performed frequently with minimal training or experience. The home pregnancy test is
`an example of an immunoassay designed to detect a single compound, human
`chorioni¢ gonadotropin, from a urine sample. LFAs are also commercially available for
`use in food and water safety, for detection of Escherichia coli, Salmonella, Legionella,
`etc.; food processing and food safety, for detection of food allergens such as peanuts,
`shellfish, etc.; clinical medicine, for detection of hCG, HIV, hepatitis C, etc.; and
`homeland defense (anthrax, botulinum toxin).
`
`A lateral flow test strip mounted within a hinged test card (claims 13 and 14-new
`
`limitation) would have been an obvious design choice which would not be expected to
`
`affect the outcome of the immunoassays.
`
`It would have been obvious to one skilled in the art to modify the combination of
`
`Horii and Nakatomi to include a prior step of obtaining a sample for a gram positive
`
`blood culture as claimed, because it is more efficient to first determine that a blood
`
`sample is infected with a gram positive bacteria before testing for the specific type of
`
`bacteria (Staphylococcus aureus) and the antibiotic resistance status. For example, if
`
`

`

`Application/Control Number: 15/159,457
`
`Page 12
`
`Art Unit: 1645
`
`there is no gram positive bacterial infection, then there is no reason to test for a
`
`Staphylococcal infection.
`
`It would have been obvious to one skilled in the art to modify the immunoassay of
`
`Horii, detecting a particular gram positive bacteria present in a sample using Protein A,
`
`to detect an enzyme (coagulase) as disclosed by Wolz and conduct a second
`
`immunoassay to detect antibiotic resistance, since doing so would increase efficiency
`
`by allowing quick determination of both bacterial species and antibiotic resistance at
`
`approximately the same time. Additionally, replacing Protein A in the immunoassay with
`
`coagulase would be obvious to one skilled in the art because, it detects a different
`
`protein, which allows for a more convincing analysis than just the detection of Protein A.
`
`For example, although other strains of Staphylococcus are coagulase positive, an assay
`
`using coagulase instead of Protein A could help in establishing that a Staphylococcal
`
`infection is present, especially if coupled with a Protein A assay. Wolz specifically
`
`discloses that the enzyme is coagulase (see above analysis).
`
`It was well known in the prior art at the time the invention was made that
`
`methicillin resistant S.aureus was a huge problem. It is routinely assayed for in
`
`infections of the skin. Following an assay for detection of coagulase with another
`
`immunoassay for antibiotic resistance would have been an obvious course of action for
`
`one of ordinary skill in the art as it would be needed to determine the course, type and
`
`regimen of antibiotics to be given to a patient. Accordingly, what is claimed was well
`
`known in the prior art at the time the invention was made.
`
`

`

`Application/Control Number: 15/159,457
`
`Page 13
`
`Art Unit: 1645
`
`12.
`
`Claims 10-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being
`
`unpatentable over Huang et al (Clinical Chemistry September 2004 vol. 50 no. 9 1673-
`
`1674) and Lambert et al (US 20959250141 A1) in view of Nakatomi et al (Microbiology
`
`and Immunology. 1998. 42: 739-742. "A rapid latex agglutination assay for the detection
`
`of penicillin-binding protein 2'").
`
`Huang et al teach the quick detection of S.aureus protein A by immune-PCR.
`
`The protocol for immune-PCB was a modified vazsi‘sicin oi the modified protocoi o1 Chan-:3 and l-iuang (gt (Fig.
`,..
`
`lied ). Briefly, mime-titer piates: were coated with 50 uwa-zasii (it anti-proteasin A igCE (l u mg/L in gzz-hosphate-
`
`buttered saiine} 122st 1 h £313? °C:, washed five times, ahszi hlcscked with 175 pL of the BSA diloeni ‘i-Cst
`
`h at 3‘? °C:.
`
`The piates were washed five times, and 533 ill. of 10-1old serial diiutad antigen (protein A; life—10””: g/rnt.) was
`
`added t0 each weli‘ After incubation for i h at 37 ”C, the piatea were washed five times, and 50 at. of the
`
`hioiiriyiated anti-protein A (”l pgil.) was added to each welt The plates were inwbateizi at ’3? “(3101' 1 h and then
`
`washed 12 times; 50 uL (it the avidih--i)iotihylaie-::l AGNA complex (1:10 000 (iiiutioh) was then added to each
`
`weil. The plates were again incubated at :5? DC for l h and washed 1:? times before the PC .step. The negative
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`oontroi was performed in the same way, except that the BSA diiuent “was substituted for the antigen soiutioh.
`
`The butler used throughout 101' plate washing was phosphate-buliered saline containing 0.5 niLr'L 'i'ween 20,
`
`whereas; the SEA diluent was used for the dilution of antigen, blotinylated antibody, avidih, and the avidin-
`
`biotinyiated ARENA compiex.
`
`Nakatomi teaches an immunoassay to detect the presence of a marker for
`
`antibiotic resistance (abstract), wherein the particular antibiotic is methicillin (abstract;
`
`Nakatomi shows that anti-PBP2a antibodies specifically detects methicillin resistant
`
`Staphylococcus aureus. One skilled in the art will readily understand that this showing
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`Application/Control Number: 15/159,457
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`Page 14
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`Art Unit: 1645
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`indicates that anti-PBP2a antibodies detect the particular antibiotic resistance marker,
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`namely: methicillin.).
`
`Lambert et al teach that lateral flow assays and devices were very well known in
`
`the prior art at the time the invention was made for a rapid test for antigens. Lambert et
`
`al specifically teaches the detection of S.aureus through dominant proteins. See
`
`specification at:
`
`[0002] Many Lateral Flow Assays (LFAs) are immunoassays that can be used to
`detect chemical or biological agents in various media including food, water, blood, urine,
`and saliva. The most commonly used LFA is the home pregnancy test which is
`performed frequently with minimal training or experience. The home pregnancy test is
`an example of an immunoassay designed to detect a single compound, human
`chorioni¢ gonadotropin, from a urine sample. LFAs are also commercially available for
`use in food and water safety, for detection of Escherichia coli, Salmonella, Legionella,
`etc.; food processing and food safety, for detection of food allergens such as peanuts,
`shellfish, etc.; clinical medicine, for detection of hCG, HIV, hepatitis C, etc.; and
`homeland defense (anthrax, botulinum toxin).
`
`Although the reference do not specifically comprises prior to step a, the step of
`
`obtaining a sample from a gram positive blood culture, it would have been obvious to
`
`one skilled in the art to modify the combination of Huang, Lambert and Nakatomi to
`
`include a prior step of obtaining a sample for a gram positive blood culture as claimed,
`
`because it is more efficient to first determine that a blood sample is infected with a gram
`
`positive bacteria before testing for the specific type of bacteria (Staphylococcus aureus)
`
`and the antibiotic resistance status. For example, if there is no gram positive bacterial
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`infection, then there is no reason to test for a Staphylococcal infection.
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`Application/Control Number: 15/159,457
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`Page 15
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`Art Unit: 1645
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`It would have been obvious to one skilled in the art to combine the immunoassay
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`of Huang and Lambert (the first immunoassay) with the monoclonal antibodies
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`disclosed by Nakatomi to detect a marker of antibiotic resistance (PBP2a) as is claimed
`
`in this application, because doing so would increase efficiency by allowing quick
`
`determination of both bacterial species and antibiotic resistance at approximately the
`
`same time. Further it would have been obvious to one skilled in the art to use the anti-
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`PBP2a monoclonal antibodies in a second immunoassay, since once a monoclonal
`
`antibody has been developed including it in an immunoassay is a procedure obvious to
`
`one skilled in the art because once a monoclonal antibody has been developed
`
`including it in an immunoassay is a simple and straight forward procedure as one skilled
`
`in the art can understand.
`
`It was well known in the prior art at the time the invention was made that
`
`methicillin resistant S.aureus was a huge problem. It is routinely assayed for in
`
`infections of the skin. Following an assay for detection of coagulase with another
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`immunoassay for antibiotic resistance would have been an obvious course of action for
`
`one of ordinary skill in the art as it would be needed to determine the course, type and
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`regimen of antibiotics to be given to a patient. A lateral flow test strip mounted within a
`
`hinged test card (claims 13 and 14-new limitation) would have been an obvious design
`
`choice which would not be expected to affect the outcome of the immunoassays.
`
`Accordingly, what is claimed was well known in the prior art at the time the invention
`
`was made.
`
`Correspondence regarding this application should be directed to Group Art Unit 1645.
`Papers related to this application may be submitted to Group 1600 by facsimile
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`

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`Application/Control Number: 15/159,457
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`Page 16
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`Art Unit: 1645
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`transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in
`Remsen. The faxing of such papers must conform with the notice published in the
`Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is
`571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
`
`Information regarding the status of an application may be obtained from the
`Patent Application Information Retrieval (PAIR) system. Status information for
`published applications may be obtained from either Private PAIR or Public
`PAIR. Status information for unpublished applications is available through Private PAIR
`only. For more information about the PAIR system, see http://pair~direct.usgtogov.
`Should you have questions on access to the Private PAIR system, contact the
`Electronic Business Center (EBC) at 866-217-9197 (toll-free).
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Jennifer E. Graser whose telephone number is (571)
`272-0858. The examiner can normally be reached on Monday-Thursday from 8:00 AM-
`6:30 PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`supervisor, Gary \ecixo can be reached on (571) 272-0835.
`
`Any inquiry of a general nature or relating to the status of this application should
`be directed to the Group receptionist whose telephone number is (571) 272-0500.
`
`8/16/17
`
`/Jennifer E. Graser/
`
`Primary Examiner, Art Unit 1