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 Arguments
In the response, dated 12/17/2025, the Applicant provided arguments to the previous rejections, and claim amendments. The Applicant has canceled claim 20 and replaced it with claim 40, and as such, the 35 USC 112(d) rejection is withdrawn. Based upon the Applicant’s amendment to claim 35, the 35 USC 112(a) Scope of Enablement rejection is withdrawn. However, the Applicant should be directed to the wording of the previous rejection, as it continues to be relevant, since the rejection was not based upon proliferation, which is claimed in claim 34, it was based upon osteogenesis, which is claimed in the independent claim. By specifically claiming “administering to cells” the claims lack enablement for showing osteogenesis of all cells. The independent claim was not previously rejected under 35 USC 112(a) Scope of Enablement, because the claimed using is suggestive of in vivo administration, which does show enablement; previous claim 35 defined “using” as a culture method. As such, the Applicant’s amendment to claim 21 provides for the same scope of enablement issues. These claims will be rejected under 35 USC 112(a) Scope of Enablement, for the reasons provided in the previous rejection. The rejections will be modified to account for the claim amendments.
On page 7 of the Applicant’s Arguments, the Applicant points to the amendment to the independent claim, changing “using” to “administering.” The change in language provides for a withdrawal of the 35 USC 101 rejections to claims 21-33 and 39.
On pages 7-12 of the Applicant’s Arguments, the Applicant points to the newly claimed amendment as providing special and unexpected features. While these are absolutely notable, and improve the patentability of the claimed invention, the independent claim also claims “or a culture of the megakaryocytes.” Hirose explicitly indicates that one of the embodiments includes “a culture of megakaryocytes.” The exact language used in the Hirose reference would suggest that the claimed “culture of megakaryocytes” is identical to the “culture of megakaryocytes” providing in Hirose; there is nothing in the claims to suggest that the “culture of megakaryocytes” is absent platelets. If Hirose teaches the same “culture of megakaryocytes,” all of the features described in the Arguments must be inherent to the “culture of megakaryocytes” described in Hirose.
Based upon the Applicant’s Arguments and amendments, the previous 35 USC 103 rejections are maintained for the reasons provided previously. The 35 USC 112(a) Scope of Enablement rejection has been modified, now that the claimed method explicitly provides for “inducing osteogenesis comprising administering to cells.” The amendment to claim 21 has provided for a withdrawal of the 35 USC 101 rejections. It is noted that claim 20 has been canceled and is now written as claim 40; claim 40 is rejected under 35 USC 103 in the same manner claim 20 was.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint 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.
Claims 21-34 and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inducing differentiation of certain cells, like mesenchymal stem cells, does not reasonably provide enablement for any cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to perform the invention commensurate in scope with these claims. The claims are drawn to a method of inducing osteogenesis by treating “a cell” with the composition described in claim 21. Since the only cell-types that would reasonably be expected to be inducible into osteogenic cells are certain types of stem cells, progenitor cells, and precursor cells, the method claiming any cell is far broader than the specification can support. There is no reasonable evidence to suggest that any cell can be induced into an osteogenic lineage; even if the claims were limited to animal cell or mammalian cell, there is absolutely no support from the specifications that the claimed material can induce osteogenic differentiation in any cell. For example, a hepatocyte would be consistent with the claimed method, but there is no evidence to suggest that a hepatocyte would be capable of an osteogenic induction.
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 21-35 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hirose, et al (US Pat 10,851,343) and Karageorgiou, et al (Biomaterials, 26, 5474-5491, 2005) and evidenced by Choi (Osteoimmunology: Advanced in Experimental Medicine and Biology: Volume 658, Springer, New York, 2010) and Chevallier, et al (Biomaterials, 31, 270-278, 2010 [IDS Reference]). Hirose describes a composition that is consistent with the claimed megakaryocyte composition, specifically describing “a culture of megakaryocytes.” See column 2, lines 5-17. Hirose does not state using a scaffold or using the composition to induce osteogenesis.
Choi provides a review of megakaryocyte-generated conditioned medium that appears consistent with the composition disclosed in Hirose and notes that the factors in the medium suppress osteoclastic differentiation and help induce osteogenic differentiation. See page 37, 1st [incomplete] paragraph. As such, although Hirose is silent on the matter, the ordinary artisan would have a reasonable expectation that the megakaryocyte composition of Hirose would have the growth factors that help induce osteogenesis.
Karageorgiou provides a review paper discussing the importance of scaffold for the induction of osteogenesis. See page 5474, “Abstract” section. Based upon its presence in a review paper, it would be quite obvious to the ordinary artisan that if osteogenesis was to be induced, there would be a huge motivation to apply a scaffold to the method.
Chevallier teaches a platelet lysate that appears consistent with the claimed composition and an overlapping composition as that disclosed in Hirose. Chevallier notes that the composition would be expected to induce osteogenesis in mesenchymal stem cells. See page 270, “Abstract” section.
Although none of the prior art explicitly teach the claimed invention, and the cited prior art does not explicitly provide for motivations to combine, both scaffolds and conditioned media are widely used in cell engineering, and as discussed in the prior art, routinely used for osteogenic induction. Therefore, there would be reasonable implicit motivation for the ordinary artisan to combine tried-and-true methods of inducing osteogenesis, and reasonably expect that the combination would provide for improved results. It must be noted that the ordinary artisan is an individual with a PhD or Masters in a field of bioengineering, wherein they would be aware of the cited prior art, and they would possess the general laboratory skills to find the combination obvious and predictable.
With respect to claims 21 and 40, the cited prior makes the claimed composition and method obvious.
With respect to claim 22, Hirose teaches megakaryocyte conditioned media, as well as “treated products,” like platelets.
With respect to claims 23-33, Hirose teaches the claimed “treated product,” and as such, must teach a product that contains the claimed compounds at the claimed concentrations. Chevallier discloses overlapping compounds that would be expected in a platelet lysate, which is consistent with the claimed “treat product.”
With respect to claims 34, 37, 38, the prior art makes it clear that mesenchymal stem cells can be induced to differentiate into osteogenic cells. See Choi, page 32, “Introduction” section; Chevallier, page 270, “Abstract” section. It would be obvious for the ordinary artisan to use this cell-type.
With respect to claim 39, Hirose immortalizes the megakaryocytes. See column 9, line 39.
Conclusion
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 DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651