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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed May 14, 2026 in reply to the First Office Action on the Merits mailed December 17, 2025. Claims 1, 2, 4-6, 8-11, 21, and 22 have been amended; and claim 19 has been canceled. Claims 1-18 and 22-25 have been withdrawn. Claims 20 and 21 are under examination.
Withdrawal of Prior Objection - Drawings
The drawings have been satisfactorily amended on corrected drawing sheets in compliance with 37 CFR 1.121(d). Therefore, the objections to the drawings presented in the First Office Action on the Merits mailed December 17, 2025 are hereby withdrawn.
Claim Objections
Claims 22-25 are objected to for improper status identification. These claims have been withdrawn and thus should properly be identified accordingly as withdrawn.
Appropriate correction is required.
Claim 21 has been satisfactorily amended. Therefore, the objection to claim 21 presented in the First Office Action on the Merits mailed December 17, 2025 is hereby withdrawn.
Claim Rejections - 35 USC § 112(b)
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.
Claims 20 and 21 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.
Claim 20 stipulates that the composition being administered comprises “a platelet concentrate”. One of ordinary skill in the art cannot definitively ascertain the number or concentration of platelets that constitutes a “platelet concentrate”, which is thus distinct from a “platelet non-concentrate”, and what reference or standard the “concentrate” is based on (i.e. “concentrated” compared to what reference or standard concentration?).
Claim 21 is also indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all 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.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Albanese et al. (Immunity and Ageing. 2013; 10:23), in view of Veeramachaneni et al. (J Conservative Dentistry. 2017; 20(5): 374-377), and Pollreisz et al. (Br. J Dermatol. 2008; 159(3): abstract).
Applicant Claims
Applicant’s elected subject matter is directed to a method of “treating” the alveolar recess after tooth extraction in a human comprising administering to the human a composition comprising a platelet concentrate and a mixture of biological factors isolated from colostrum; wherein the composition does not contain IgG, IgA, and IgM.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Albanese et al. disclose methods of “treating” the alveolar recess after tooth extraction and periodontal defects in a human comprising administering to the human a composition comprising platelet-rich plasma (PRP).
Veeramachaneni et al. disclose that bovine (e.g. dairy cow) colostrum is rich in immunoglobulins, growth factors, antimicrobials, and other beneficial factors, and stimulates wound healing, tissue repair, and regeneration of body tissues, and in particular can facilitate healing of periapical bony defect.
Pollreisz et al. disclose that immunoglobulins are able to bind to platelets and cause the undesired side-effect of platelet aggregation, and can also cause intravenous thrombosis, and suggests the exercise of caution when combining packed platelets and immunoglobulins.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Albanese et al. do not explicitly disclose that the composition being administered contains a mixture of biological factors from colostrum, and that the composition does not contain IgG, IgA, and IgM. These deficiencies are cured by the teachings of Veeramachaneni et al. and Pollreisz et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Albanese et al., Veeramachaneni et al. and Pollreisz et al., outlined supra, to devise Applicant’s presently claimed method.
Albanese et al. disclose methods of “treating” the alveolar recess after tooth extraction and periodontal defects in a human comprising administering to the human a composition comprising platelet-rich plasma (PRP), wherein treatment is facilitated, at least in part, by growth factors such as TGF-b. Since Veeramachaneni et al. disclose that bovine (e.g. dairy cow) colostrum is rich in immunoglobulins, growth factors such as TGF-b, antimicrobials, and other beneficial factors, and stimulates wound healing, tissue repair, and regeneration of body tissues, and in particular can facilitate healing of periapical bony defect; and since Pollreisz et al. disclose that immunoglobulin binding to platelets can cause the undesired side effect of platelet aggregation, and can also cause intravenous thrombosis, and suggests the exercise of caution when combining packed platelets and immunoglobulins; one of ordinary skill in the art would thus be motivated to modify the Albanese et al. composition by the addition of bovine colostrum, but which has been “deprived” of immunoglobulins, such as IgG, IgA, and IgM, with the reasonable expectation that the resulting composition, when applied to an alveolar recess after tooth extraction, will successful treat the injury to promote repair and regeneration, with minimal chances of the undesired side effect of platelet aggregation and thrombosis.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings 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.
Response to Arguments
Applicant's arguments filed May 14, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that “Albanese…makes no mention of colostrum or a composition that does not include immunoglobulins IgG, IgA, and IgM”; that “Veeramanchaneni” provides “no disclosure, teaching or suggestion to combine” colostrum “with a platelet concentrate”; that “alveolar sockets are resultant from tooth extractions whereas periapical surgery removes infected tissue at the root tip” which are “different dental procedures”; that “Pollreisz makes no mention of removing/depleting immunoglobulins…in fact, Pollreisz discloses that platelet aggregation may be abrogated by adding a blocking antibody AT10 to the composition”; and “there is no teaching or suggestion to combine Pollreisz with the other cited references Albanese and Veeramanchaneni”.
The Examiner, however, would like to point out the following:
1. Neither Albanese, Veeramanchaneni, nor Pollreisz has been cited for individually anticipating the claimed subject matter under 35 USC 102. None of these cited references need to disclose each and every aspect of the claimed subject matter. None of these cited references need recite Applicant’s claims verbatim. On the contrary, the prior art rejection at issue here is under 35 USC 103, based on the combination of the cited references, and what these references disclose or reasonably suggest to one of ordinary skill in the art, who is one of ordinary creativity and not an automaton.
2. The specific reasons why one of ordinary skill in the art would combine the references to arrive at the presently claimed subject matter has been discussed in the prior art rejection itself. Applicant does not appear to have addressed the underlying basis for the actual prior art rejection that has been made and explained.
3. Contrary to Applicant’s assertion, the key issue is not whether tooth extraction and periapical surgery are precisely one and the very same dental procedure. Rather, both dental procedures produce a condition requiring dental/bony tissue repair and regeneration. Albanese and Veeramachaneni both address treating the condition requiring dental/bony tissue repair and regeneration. Albanese discloses that dental tissue repair and regeneration can be achieved by administering to the human a composition comprising platelet-rich plasma (PRP). Veeramachaneni discloses that dental tissue repair and regeneration can be achieved by administering bovine (e.g. dairy cow) colostrum. It would no doubt be obvious to combine the PRP and the colostrum to achieve the same effect, i.e. dental tissue repair and regeneration.
4. Pollreisz discloses that immunoglobulins are able to bind to platelets and cause the undesired side-effect of platelet aggregation. As just noted, supra, Albanese, the cited primary reference, discloses that dental tissue repair and regeneration can be achieved by administering to the human a composition comprising platelet-rich plasma (PRP). Obviously, then, the platelets are a key critical element. Albanese further discloses that the desired treatment is facilitated, at least in part, by growth factors such as TGF-b. Since Veeramachaneni discloses that bovine (e.g. dairy cow) colostrum is rich in growth factors such as TGF-b, antimicrobials, and other beneficial factors, these are key critical elements that must be retained. However, one of ordinary skill in the art would recognize that one sure way to prevent the platelet aggregation due to IgG, IgA, and IgM is to remove these immunoglobulins. The growth factors such as TGF-b and other beneficial factors found in colostrum will still be there to provide additional benefits for tissue repair and regeneration over PRP alone due to these additional beneficial factors.
5. Hence, one of ordinary skill in the art, who is one of ordinary creativity, in view of the cited prior art, could have arrived at the claimed subject matter with a reasonable expectation of success. Applicant has provided no hard evidence to the contrary.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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