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 .
Election/Restrictions
Applicant's election with traverse of claims 1-19 in the reply filed on 7/22/2025 is acknowledged. The traversal is on the ground(s) that the cited Nunez reference does not teach all of the limitations of claim 1. This is not found persuasive because the standard does not require this. It is required that the technical features shared among the claimed groups are not special technical features because they do not make contributions over the cited art which is the case herein.
The requirement is still deemed proper and is therefore made FINAL.
Claims withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected medical device, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/22/2025.
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.
Claim(s) 1-2, 4-12, 14-16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Owens et al. (USPGPub2012/0040013).
Regarding claims 1, Owens teaches that it is known to form a 3D acellular tissue matrix (ATM)(abstract and Fig.1) by wetting a combination of an ATM, polymer and solvent with an aqueous media [0043] wherein the mixture may be further placed in a mold to shape it if necessary [0044].
Regarding claim 2, the treatment of the ATM with the aqueous media is described as “soaking”, reasonably implying at least a partial immersion (claim 34).
Regarding claim 4, the aqueous media of Owens is not stated a including or requiring pyrogens and as such it is implicit that they are not present.
Regarding claim 5, the ATM of Owens comprises the same types of acellular matric material [0027] and the same polymers of the current application (claim 13) wherein the composition of the prior art would necessarily form the same product having the same color as the product of the current claims.
Regarding claim 6, the molding described above takes place at a time when the media has been contacted with water and therefore would be considered “wet molding”.
Regarding claims 7-8, Owens teaches wherein the matrix employed may be from human or porcine origins (claim 54).
Regarding claim 9, Owens further teaches the use of dermal matrix (claim 54).
Regarding claim 10, providing the matrix material of Owens alone without any other steps reads upon preparing it to allow adhesion of the polymer provided wherein the matrix is later combined with an already formed polymer/solvent combination [0005].
Regarding claims 11-12, Owens does not teach the use of modified temperatures as relates to the use of the matrix material during surgery [0049]. As such it is reasonably implicit that the use of the material of Owens take place and operating room temperatures or temperature similar to those, well below the approximation denaturation temperature of collagen (~140-149F).
Regarding claim 14, Owens teaches that the ATM may be prepared via cryofracturing which would read upon mechanical surface treatment prior to use of the ATM in the implantable composition [0063].
Regarding claim 15, the soaking of Owens (claim 34) read upon “dip coating” which comprises placing the object to be coated in a fluid for a time.
Regarding claim 16, Owens teaches wherein the matrix is later combined with an already formed polymer/solvent combination [0005] which may comprise DMSO [0036-0039], a known polar solvent.
Regarding claim 18, Owens teaches the use of poly-4-hydroxybutyrate (claim 44)(P4HB) which is a polyhydroxyalkanoate.
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.
Claim(s) 3, 13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Owens et al. (USPGPub2012/0040013) as applied to claims 1-2, 4-12, 14-16 and 18 above.
Regarding claim 3, the teachings of Owens are as shown above. Owens is silent as to the soaking time employed. However, several points should be considered. First, likely the soaking time of Owens is not critical in that they are being implanted in the body and would likely continue to absorb fluid from the body up to a point even if soaking were not continued in vitro. Second, the matrix of Owens is particulate until soaked. Therefore it would reasonably need at least a certain amount of time to absorb fluid in order to be moldable as described above. Finally soaking for extended periods of time would only allow absorption up to a certain amount of saturation of the particulate matrix such that excess time thereafter would be unnecessarily wasteful. Therefore, in the absence of criticality of the specific soaking time of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the soaking time of Owens within a range in order to ensure at least minimal moldability of the composition employed while not largely wasting time soaking the composition past a point of saturation, thereby wasting production time and extending surgical time possibly. Discovery of optimum value of result effective variable in known process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
Regarding claim 13, the teachings of Owens are as shown above. Owens is silent as to the amount of residual moisture present in his ATM although Owens explicitly does teach a desire to employ freeze drying on the ATM in order to do away with residual moisture [0064]. However, several points should be considered. First, as stated, Owens explicitly shows a desire to reduce residual moisture, possibly to prevent spoilage of the composition for longer storage times or for other purpose. However, it is additionally noted that it is not reasonably possible time remove absolutely all moisture from the composition of Owens, wherein longer more extensive dehydration processes would extend production time and raise costs. As such, one employing the practices of Owens would reasonably be balancing costs, time and shelf life to arrive at some optimized moisture content level suiting the manufacturer and end user. Therefore, in the absence of criticality of the specific moisture content of the current claims, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the moisture content of Owens within a range in order to ensure reduced costs and production time while also balancing factors such as shelf life.
Regarding claim 17, the teachings of Owens are as shown above. Owens fails to teach vacuum degassing of his employed polymer solution. However, the examiner is taking Official Notice to inform the applicant that vacuum degassing of liquid compositions used in the manufacture of other components is common in a large number of fields as a basic quality control measure. Frequently liquids, when exposed to air or during manufacture, allow contaminant gases and volatiles to dissolve within them creating contaminants and degassing is employed in order to prevent this and the effects of the contaminants in the composition. This is employed in drug manufacture, chemical manufacture and in laboratories at large as a basic decontamination technique. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to bubble the composition of Owens in a vacuum as claimed as a basic quality control measure for the purpose of improving the purity and quality of the product of Owens.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Owens et al. (USPGPub2012/0040013) as applied to claims 1-2, 4-12, 14-16 and 18 above and further in view of Pathak et al. (WO2006/026325).
Regarding claim 19, the teachings of Owens are as shown above. Owens fails to teach wherein the solvent used for the P4HB is acetone. However, Pathak teaches that acetone is known to be used as a substitute for DMSO for the dissolution of P4HB in medical implants provision operations. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the acetone of Pathak for the DMSO of Owens as a simple substitution of one known P4HB solvent for another employed for the manufacture of medical implants wherein the results of the substitution would have been predictable based upon the teachings of Pathak.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J BOWMAN whose telephone number is (571)270-5342. The examiner can normally be reached Mon-Sat 5:00AM-11:00AM.
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/ANDREW J BOWMAN/Examiner, Art Unit 1717