DETAILED ACTION
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 Amendment
The Amendment filed 11/18/2025 in which claims 1, 4, and 8 were amended, has been entered.
Claims 1-15 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/06/2025 after the Nonfinal Office Action mailed on 08/20/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
(Previous objections, withdrawn as to claim 4, maintained as to claims 1, 2, and 8). Applicant’s amendments to claims 1, 2, 4 and 8 have overcome previous objections to those claims.
Claim Rejections - 35 USC § 112
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.
(Previous rejection, withdrawn as to claims 1-15) Claims 1-15 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 1-15 as submitted on 11/18/2025.
Applicant's arguments regarding the previous rejection under 35 U.S.C. 112(b), have been fully considered and found persuasive. The previous rejection of claims 1-15 is herein withdrawn.
(New rejection, necessitated by amendment as to claims 1-15) Claims 1-15 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Amended claims 1 and 8 recite “the gelatin hydrolysate is derived from vertebrate animals”. It is unclear what the term “derived” means because the Specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, it is not clear if the term “derived” encompasses gelatin hydrolysate polypeptides which share 100% or less sequence identity with those isolated or extracted from vertebrate animals. Instant Specification refers to gelatin hydrolysate polypeptides extracted from animal skins or the like, as well as those obtained by chemically synthesis, gene recombination, or a synthetized polypeptide (Specification, pages 5-6). The scope of the claimed invention is indefinite where the meets and bounds of the term were not defined in the Specification. Therefore, the claims are indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. Further, it is noted that under BRI gelatin hydrolysate polypeptides obtained by chemically synthesis, gene recombination, or a synthetized polypeptide read on the term “derived”. For purposes of compact prosecution and applying prior art, claims 1, 8 were interpreted herein consistent with the Specification as referring to a gelatin hydrolysate polypeptides extracted from animal skins or the like, as well as those obtained by chemically synthesis, gene recombination, or a synthetized polypeptide (Specification pages 5-6).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 1-4, 8 and 9) Claims 1-4, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bouwstra et al., as evidenced by Hitchcock DI. (prior art of record).
See claims 1-4, 8 and 9 as submitted on 11/18/2025.
Regarding claim 1, the teachings of Bouwstra et al. and Hitchcock are explained in detail in the previous Office Action mailed on 08/20/2025. Amended claim 1 recites the new limitation of “wherein the gelatin hydrolysate is derived from vertebrate animals” (see rejections under 35 U.S.C. 112(b) above). However, this limitation is already taught by Bouwstra et al. Specifically, Bouwstra et al. teach for example, recombinant gelatin polypeptides identical to natural human collagen amino acid sequences (such as for example COLlAl , COL3Al, etc.) or fragments thereof, but also non-human gelatin sequences (such as rat, rabbit, mouse etc.) (¶ [0019]). It is noted that the gelatin hydrolysate of Bouwstra et al.’s is identical to natural human collagen and therefore meets the interpretation of new limitation of claim 1 set forth above (see rejections under 35 U.S.C. 112(b) above). See MPEP 2112.01. I. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. With respect to the recitation of “a weight average molecular weight of no more than 1000”, absent evidence to the contrary the teachings of Bouwstra et al. of an average molecular weight is for example 6 kDa meet this limitation given the mathematical relationship of weight average molecular weight and average molecular weight, as pointed out by Applicant in the Remarks (page 7) submitted on 11/18/2025.
Regarding claim 2, it is noted that no amendments were introduced to claim 2 in the amendment filed on 11/18/2025. As previously explained, Bouwstra et al. teach a mixture of gelatin on water wherein the average molecular weight is for example 6 kDa (¶¶ [0008], [0009], [0051]; claim 4). Absent evidence to the contrary the teachings of Bouwstra et al. of an average molecular weight is for example 6 kDa meet the limitations of claim 2 given the mathematical relationship of weight average molecular weight and average molecular weight, as pointed out by Applicant in the Remarks (page 7) submitted on 11/18/2025.
Regarding claim 3, it is noted that no amendments were introduced to claim 3 in the amendment filed on 11/18/2025. As previously explained, Bouwstra et al. teach a gelatin in water wherein the gelatin is an alkaline hydrolyzed gelatin (¶ [0051]).
Regarding claim 4, it is noted that no new limitations were introduced to claim 4 in the amendment filed on 11/18/2025. The amendment was made to overcome the previous objection set forth in the Non-Final Office Action mailed on 08/20/2025. As explained above, Bouwstra et al. teach wherein the gelatin is present at for example 10% (where 10% of the total weight is gelatin and 90% is water), (¶ [0051]).
Regarding amended claim 8, similar to amended claim 1, claim 8 recites the new limitation of “wherein the gelatin hydrolysate is derived from vertebrate animals” (see rejections under 35 U.S.C. 112(b) above). However, this limitation is already taught by Bouwstra et al. Specifically, Bouwstra et al. teach for example, recombinant gelatin polypeptides identical to natural human collagen amino acid sequences (such as for example COLlAl , COL3Al, etc.) or fragments thereof, but also non-human gelatin sequences (such as rat, rabbit, mouse etc.) (¶ [0019]). Furthermore, it is noted that while Bouwstra et al. do not explicitly teach the gelatin hydrolysate was extracted or isolated from a vertebrate animal, the gelatin hydrolysate of Bouwstra et al.’s is identical to natural human collagen and therefore meets the new limitation of claim 8. See MPEP 2112.01. I. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. With respect to the recitation of “a weight average molecular weight of no more than 1000”, absent evidence to the contrary the teachings of Bouwstra et al. of an average molecular weight is for example 6 kDa meet this limitation given the mathematical relationship of weight average molecular weight and average molecular weight, as pointed out by Applicant in the Remarks (page 7) submitted on 11/18/2025.
Regarding claim 9, it is noted that no amendments were introduced to claim 9 in the amendment filed on 11/18/2025. As previously explained, Bouwstra et al. teach a liquid virus stabilizer comprising a synthetic gelatin in lyophilized form (powder, as recited in claim 9) (¶¶ [0048], [0051]).
The rejection is maintained for reasons of record.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 5-7 and 10-15) Claims 5-7 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bouwstra et al., as evidenced by Hitchcock as applied to claims 1-4, 8 and 9 above, and further in view of Koyama et al. (prior art of record).
See claims 5-7 and 10-15 as submitted on 11/18/2025.
Regarding claim 5, it is noted that no amendments were introduced to claim 5 in the amendment filed on 11/18/2025. As previously explained, Bouwstra et al. as evidenced by Hitchcock teach the virus stabilizer of claim 1. Bouwstra et al. do not teach wherein the aqueous medium contains a salt having a buffering action.
However, Koyama et al. teach a stabilizer for live varicella virus comprising gelatin hydrolysate in an aqueous solution, wherein the aqueous medium is phosphate buffered saline (PBS) which contains a salt, for example NaCl or KCl salt, having the buffering action of maintaining a stable pH within the solution for the purpose of providing greater stability to live varicella virus (Abstract, columns 3, 4, 9, 10, Table 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated a salt as taught by Koyama et al. into the virus stabilizer taught by Bouwstra et al. for the benefit of providing greater stability to a live virus. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating a salt in the virus stabilizer taught by Bouwstra et al. given that the methods of formulating live virus compositions comprising gelatin hydrolysate are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claims 6 and 7, it is noted that no amendments were introduced to claims 6 and 7 in the amendment filed on 11/18/2025. As previously explained, Koyama et al. teach the stabilizer for live varicella virus comprising gelatin hydrolysate in an aqueous solution and further comprising sucrose and glutamate or glutamic acid (Example 5, columns 9 and 10).
Regarding claim 10, it is noted that no amendments were introduced to claim 10 in the amendment filed on 11/18/2025. As previously explained, Koyama et al. teach a live virus-containing composition comprising a virus stabilizer comprising gelatin hydrolysate (Abstract, columns 3, 4).
Regarding claims 11 and 12, it is noted that no amendments were introduced to claims 11 and 12 in the amendment filed on 11/18/2025. As previously explained, Koyama et al. teach a live virus-containing composition comprising live varicella virus, a member of the herpesvirus family of DNA enveloped viruses. Koyama et al. further teach the use of a transgenic strain of varicella termed rVH17-5 Oka strain (columns 1, 17).
Regarding claims 13-15, it is noted that no amendments were introduced to claims 13-15 in the amendment filed on 11/18/2025. As previously explained, Koyama et al. teach differences in virus titer upon storage of the virus-containing composition (column 13, Table 4). However, with respect to the recitations of:
“wherein in the virus-containing composition, a difference between the logarithmic reduction value of a virus titer in the case of storage at 25°C for 21 days and the logarithmic reduction value of a virus titer in the case of storage at -80°C for 21 days is not more than 1.5 log” in claim 13,
“wherein in the virus-containing composition, a difference between the logarithmic reduction value of a virus titer in the case of storage at 4°C for 210 days and the logarithmic reduction value of a virus titer in the case of storage at -80°C for 210 days is not more than 1.0 log” in claim 14, and
“wherein in the virus-containing composition, the logarithmic reduction value when freezing and thawing is repeated three times is not more than 0.3 log” in claim 15,
it is noted that these recitations do not impart any additional structural features to the virus-containing composition comprising a virus stabilizer of claim 10, therefore these recitation is considered to flow from the features already present in the virus-containing composition comprising a virus stabilizer as recited in claim 10. Therefore, any virus-containing composition comprising a virus stabilizer in the prior art having the all of the structural limitations recited in claims 1 and 10 would be capable of stabilizing a virus such that the logarithmic reduction value of a virus titer upon storage is not more than 1.5 log, 1.0 long or 0.3 log as recited in claims 13-15. It is noted that the prior art teaches the exact embodiments of claims 1 and 10, as explained above, for the purpose of stabilizing a virus such that a virus titer upon storage is not significantly reduced.
The rejection is maintained for reasons of record.
Response to Arguments
Applicant's arguments in reference to previous rejections under 35 USC § 103 filed on 11/18/2025 have been fully considered but they are not persuasive.
Applicant contends on page 9 of the Remarks submitted on 11/18/2025:
[A]mended Claims 1 and 8 specify the feature that "the gelatin hydrolysate is derived from vertebrate animals." In contrast, Bouwstra discloses vaccine compositions containing recombinant or synthetic gelatin as a stabilizer. Bouwstra states that gelatin derived from naturally occurring collagen, obtained from hides and bones of animals, has many disadvantages: possibility of immediate hypersensitivity, known as anaphylactic shock, presence of impurities, the fact that the nature of the composition is not clearly defined and thus not reproducible, and, in case of bovine gelatin, risk of contamination of the gelatin with factors responsible for the occurrence of Bovine Spongiform Encephalitis (BSE) and Creutzfeld-Jakob Disease (nvCJD). Paragraph [0006] of Bouwstra. Bouwstra teaches not using problematic animal-derived gelatin but using recombinant or synthetic gelatin, which provides advantages over the animal-derived gelatin (purity, etc.), to solve the problem. See, paragraph [0008] of Bouwstra.
In addition, Gelatin A (a natural, animal-derived gelatin) in Example 1 of Bouwstra, is contraindicated for use as a vaccine composition in Bouwstra. Therefore, Applicant submits that the disclosure in Bouwstra constitutes a teaching away from the invention of amended Claims 1 and 8 of the present Application.
In view of the foregoing, Applicant submits that the present claimed invention would not have been prima facie obvious to a person having ordinary skill in the art based upon the cited references. Accordingly, withdrawal of the rejections is requested.
In response:
The instant rejection is in view of instant claim language. As indicated above the term “derived from” fails to the scope of the invention as required by 35 USC § 112(b). Further, as explained above in detail, the gelatin hydrolysate of Bouwstra et al.’s is identical to natural human collagen and therefore meets the new limitation of a gelatin hydrolysate derived from vertebrate animals. See MPEP 2112.01. I. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Thus, in view of the instant claim language, it is maintained that it would have been prima facie obvious for one of ordinary skill in the art to arrive with reasonable expectation of success at the claimed invention.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672