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 .
The Examiner of this applicant has changed from Jacob Boeckelman to Danielle Johnson.
Claims 1-19 are pending.
Election/Restrictions
Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/15/2025.
Applicant’s election without traverse of the buffer, sodium bicarbonate, the growth factor, bone morphogenetic protein (BMP) and scaffold, mineral and collagen, claims 13-18 in the reply filed on 12/15/2025 is acknowledged.
Claim 19 was not listed in the restriction requirement and has been considered as part of Group III. Therefore, claims 13-19 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/18/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
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.
Claim 13-19 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 13 recites “providing a scaffold” which is indefinite. The metes and bounds of what in encompassed by the term scaffold cannot be deciphered. The broader scope of the term can encompass various structures used in construction. The specification details that the scaffold can be comprised of collagen, hyaluronan, or other protein, amino acid, GAG, and/or biocompatible material (page 11, lines 30-33). Therefore, for the purpose of compact prosecution the scope of scaffold has been interpreted as encompassing any biological material such as bone, tissue proteins, etc.
Additionally, claim 13 recites “growth factors or agents” the scope of the term “agents” is indefinite. While the specification details the scope of the term “growth factors” the scope of what is encompassed by the term agents cannot be deciphered. Therefore the metes and bounds of what agents are combined with scaffold in solution is unclear.
Claim 15 recites the abbreviation “GAG” without its corresponding plain meaning which is indefinite. The abbreviation can read on any product having the abbreviation, including the peptide Glycine-Alanine-Glycine, the polysaccharide glycosaminoglycan or a device used to keep the mouth open during a dental procedure. Claim 15 also recites “other protein” and “biocompatible material” which are vague and indefinite. In the present claim, the metes and bounds of the terms cannot be deciphered.
Claims 14 and 16-19 are rejected for depending on rejected claim claim 13.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Govil (WO 2019/067942; published April 4, 2019).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicant claims a method of enriching bound growth factors in a medical implant comprising:
providing a scaffold, preferably selected from mineral and collagen,
combining the scaffold in solution with growth factors or agents, preferably bone morphogenetic protein (BMP); and
raising the pH of the solution from a first level to a second more basic level by adding a base or buffer, preferably selected from sodium bicarbonate.
Govil claims a method of enriching bound growth factors in a medical implant comprising:
providing a scaffold,
combining the scaffold in solution with growth factors or agents; and
raising the pH of the solution from a first level to a second more basic level by adding a base or buffer (claim 24).
The scaffold is derived from allograft, xenograft or created synthetically (claim 26; page 1, lines 32-34).
The scaffold is comprised of collagen, hyaluronan, protein, amino acids, peptide or glycosaminoglycan (GAG) and/or biocompatible material (claim 27; page 1, lines 25-29).
The growth factors or agents can comprise VEGF, bFGF, aFGF, TGFB-1, PDGF, IGF or any other growth factor or tissue growth stimulative or differentiation agent (claims 28 & 29; page 3, lines 1-4).
The first pH level is acidic (claim 30).
The buffer or base comprises one or more of sodium hydroxide, sodium bicarbonate, phosphate buffer, sodium chloride or calcium salt (claim 31).
Govil claims a medical implant kit comprising the medical implant according to claim 24 and an applicator (claim 31).
Example 6 discloses enrichment and increased bind methods increase growth factor binding by combining a bone composition in a solution with growth factors and raising the acidic pH by adding sodium bicarbonate (page 25, lines 12-21). Mineralized cortical bone is exposed to hydrochloric acid and then pH is raised to above 4 so that growth factors and growth agents bound to the mineral and loosely bound collagen are released (page 26, lines 1-22). Medical implants derived from allogeneic or xenograph are also disclosed (Example 7, page 26, lines 25-28).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12 of U.S. Patent No. 10,660,986 (herein’986). Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are drawn to a medical implant produced by the method of claim 13, whereas ‘986 discloses an implant comprising allograft bone processed by osmotically lysing bone marrow cells in the allograft cancellous bone to enrich for cells by exposing the allograt to water and acetic acid, following lysing the cells and growth factors are released which binds to the allograft bones and when the implant is implanted the implant comprises cells resistant to lysing and the growth factors associated with the allograft. Claim 11 further comprises a step of attaching the released growth factors to the cortical bone.
It is proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. ‘986 teach that once implanted the gel binds to tissue and physiological fluids may buffer to neutralize the pH and cause the gel to solidify in situ to remain in place (column 13, lines 40-51). The scaffolds are can be freeze dried and rehydrated with 2 molar NaOH solution to reach neutral pH. (column 15, line 35 through column 16, line 51). Therefore claim 19 is obvious in view of the teachings in the patent. Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/BETHANY P BARHAM/ Supervisory Patent Examiner, Art Unit 1611