Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
RESPONSE TO APPLICANT’S AMENDMENT
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/06/26 has been entered.
2. Claims 1-6, 12, 22-25,27-31, 35 and 36 are pending.
3. Claims 1-6, 12, 22-25,27-31, 35 and 36 read on a method of treating or preventing HIV or SIV comprising administering a reservoir-depleting agent and one or more antiviral vaccinel are under consideration in the instant application.
4. 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 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.
5. Claims 1-6, 12, 22-25,27-31, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 2003/0017979 , Bruhl et al ( J of Immunol, 2001,v.166,pages 2420-2426) in view of WO 2012018856 and Moore et al ( Methods, 2019,v.154, pages 38-50) and 20220411505 and newly cited US Patent Application 20240391952
Applicant’s argument filed on 01/06/26 have been fully considered but have not been found convincing.
Applicant asserts that as amended the claims now recited that bispecific antibody with at least 95% purity. None of the prior art references teach said feature.
Newly cited US Patent application ‘952 teaches several indicated that method for purifying bispecific antibody at least to 95 % purity. US Patent application ‘952 teaches that increasing purity of bispecific antibody is important and should be used for bispecific antibodies to be used in various immunotherapeutic protocols including treating viral infections ( see entire document, paragraphs 0008, 0025, 0092, 0341 in particular)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to purified bispecific antibody that retain an Fc effector region up to 95 % purity with a reasonable expectation of success because the prior art teaches several method for said purification and indicated that increasing purity of bispecific antibody is important and should be used for bispecific antibodies to be used in various immunotherapeutic protocols including treating viral infections
As has been stated previously, US Patent Application ’ 979 teaches a method of treating HIV comprising administering to the patient a reservoir-depleting agent, comprising bispecific antibody anti-CD3/CCR5, that binds and eliminating CCR5+ cells in the patient. US Patent Application ’ 979 further teaches that said reservoir-depleting agent further comprises toxin ( see entire document, abstract, Material and Method and Discussion inparticular) and paragraphs 0016, 0028, 0030,0031 0067)
Bruhl et al ., teach a method of treating HIV comprising administering to the patient a reservoir-depleting agent, comprising bispecific antibody anti-CD3/CCR5, that binds and eliminating CCR5+ cells in the patient. Bruhl et al., further teaches that said reservoir-depleting agent further comprises toxin ( see entire document, abstract and Material and Method and Discussion in particular).
US Patent Application ’ 979 and Bruhl et al., do not explicitly teach administering antiviral vaccine.
WO 2012018856 teaches a method of treating HIV comprising administering recombinant adenovirus HIV vaccine ( see entire docunet, Abstract in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add recombinant adenovirus HIV vaccine to the method taught by US Patent Application ’ 979 and Bruhl et al., with a reasonable expectation of success because the prior art suggests that each agents can be used for treatment of HIV.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Moore et al., teach an advantages of engineering bispecific antibody that retain an Fc effector region to improve targeting ability and for treating various diseases in a patient. ( see entire document, Abstract and Discussion in particular).
US Patent’505 teach an advantages of using engineering bispecific antibody that retain an Fc effector region to improve targeting ability and for treating diseases. US Patent’505 teach that said bispecific antibody binds CD3 ( see entire document, Abstract and paragraphs 0014, 0106, 0113, 0180 in particular).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use bispecific antibody that retain an Fc effector region in the method taught by by US Patent Application ’ 979 and Bruhl et al., with a reasonable expectation of success because the prior art suggests that use of bispecific antibody that retain an Fc effector region improve targeting ability and more effective in treating diseses in a patient.
Claims 14-16, 27-31,35 and 36 are included because it would be conventional and within the skill of the art to : (i) identify an optimal CCR5 ligand (ii) determine the optimum duration, timing and means of administration of reservoir-depleting agent . Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
5. No claim is allowed.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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