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 papers filed September 30, 2025. Applicant’s reply to the restriction/election requirement of July 31, 2025 has been entered. Claim 19 has been canceled. Claims 1-18 and 20-25 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/IB2021/059513, filed October 15, 2021 under 35 U.S.C. 365(c), is acknowledged.
Acknowledgment is also made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of Italian Patent Application No. 102020000024385, filed in the Italian Republic on October 15, 2020, has been received as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group II, claims 20-25, is acknowledged. Applicant’s elections of i) “injection composition” as the species of composition, ii) “platelet-rich plasma (PRP)” as the species of platelet concentrate, iii) “activated” as the species of platelet concentrate activation status, iv) “dairy cow” as the species of colostrum source, v) “liposomes” as the species of further constituent, vi) “50 mg” as the species of amount of colostrum isolate mixture, vii) “liquid solution” as the species of composition form, viii) “human” as the species of subject being treated, ix) “alveolar recess after tooth extraction” as the species of condition being treated are all also acknowledged. The Examiner has determined that claims 20 and 21 read on the elected subject matter.
Accordingly, claims 1-18 and 22-25 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Election was made without traverse in the reply filed on September 30, 2025. Claims 20 and 21 are currently under examination.
Drawings
The drawings are objected to because of the following:
1. Figures 9, 12-14, 16, 18, 21-25, 27, 28, 30, 32-34, 36, 38-41, and 43 are not in compliance with 37 CFR 1.84(u)(1), which states, in part, that “partial views intended to form one complete view…must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation ‘FIG.’”.
2. It is further noted that in Figures 9, 12-14, 16, 18, 19, 21, 23-25, 27, 28, 30, 31, 36, 38, and 39-42, decimals are not presented in proper format for a U.S. Patent. In the United States, decimals are written with a period, not a comma. As an example, the value 2 ½ can be written as “2.5” but not “2,5”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 21 is objected to because of the following:
1. In claim 21, there is an extraneous colon between “selected from the group consisting of” and “alveolar”.
Appropriate correction is required.
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, which incorporates the limitations of claim 1, is indefinite for the following reasons:
1. Claim 20 stipulates that the composition being administered comprises “platelet concentrates”. One of ordinary skill in the art cannot definitively ascertain how the plural form, i.e. “platelet concentrates” is necessarily distinct from the singular “a platelet concentrate”, and, moreover, 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?).
2. Claim 20 stipulates that the composition being administered comprises “a colostrum isolate mixture rich in biological factors”. One of ordinary skill in the art cannot definitively ascertain if a “colostrum isolate mixture” necessarily includes or excludes colostrum, and further, what, at a minimum, constitutes a “colostrum isolate mixture”. For example, does a mixture comprising merely only two components found in colostrum constitute a “colostrum isolate mixture”? Or does the “colostrum isolate mixture necessarily contain at least two “biological factors”? Moreover, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “rich in” with respect to biological factors. Does “rich” denote the number of different biological factors, or the concentration of the biological factors, or both? What amount of biological factors constitutes “rich”, and what amount of biological factors is thus not “rich”? One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
3. Claim 20 stipulates in a wherein clause that “the composition is deprived of IgG, IgA, and IgM”. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of this limitation. For example, is the composition as a whole entirely devoid of any and all IgG, IgA, and IgM? Or, alternatively, does the composition contain whatever amount of IgG, IgA, and IgM normally present in the platelet concentrate and colostrum elements, but no additional amount of IgG, IgA, and IgM beyond this amount? Or, alternatively, does the composition contain an amount of IgG, IgA, and IgM that is lower than the amount of IgG, IgA, and IgM normally present in the platelet concentrate and colostrum elements? Or what?
Claim 21 stipulates in a wherein clause that the conditions requiring tissue repair and regeneration comprise “oral and maxillofacial surgical procedures” and that these are selected from “alveolar recess and periodontal defects”. Reference to “oral and maxillofacial surgical procedures” appears to be incongruous. Hence, surgical procedures themselves are not conditions that require tissue repair and regeneration. More specifically, alveolar recess and periodontal defects are not surgical procedures, but are in fact conditions that require repair and regeneration. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
***This issue can be resolved by deleting the phrase “comprise oral and maxillofacial regenerative surgical procedures comprising conditions selected from the group consisting of”. The claim can thus be amended to obtain the limitation “wherein the conditions requiring tissue repair and regeneration, in humans or animals, are selected from alveolar recess after tooth extraction and periodontal defects”.
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 platelet-rich plasma and colostrum; wherein the composition is “deprived” of 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 colostrum, and that the composition is “deprived” of 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.
Conclusion
No claims are allowed.
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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/DAVID BROWE/Primary Examiner, Art Unit 1617