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 .
Status
Pursuant to a preliminary amendment, claims 1-20 are pending in the application.
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 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.
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) 1-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2017/0021058 A1; published 26 January 2017) in view of Park (WO 2005/120597 A1; published 22 December 2005) and Barry et al. (US 2008/0241072 A1; published 02 October 2008).
Huang et al. discloses a composition comprising acellular/decellularized adipose tissue and matrix thereof suitable for implantation into a living body in plastic/reconstructive/cosmetic surgery or wound care or regenerative medicine procedures wherein the matrix may be dried or not dried (title; abstract; claim 1) wherein the composition may further comprise a carrier (claim 5) such as a phosphate buffered saline solution or hyaluronic acid (claim 6) wherein the matrices may be in particulate form or in the form of an injectable suspension (paragraph [0006]) wherein the matrix may be in a particulate or slurry form as a tissue/skin/dermal filler (paragraph [0011]) wherein particles may be microparticles or milliparticles (paragraph [0423]) wherein the acellular tissue may be broken into smaller components by milling or homogenization (paragraph [0468]) wherein the acellular tissue may be mechanically manipulated into a particulate form which can be resuspended in a liquid such as water or a buffer solution to form a flowable mass which may form a porous or sponge-like shaped acellular tissue which can be formed with or without lyophilization and which may have porosities controlled by selected the amount of liquid relative to the amount of particles and porosities customized for their intended use (paragraphs [0469], [0474]) wherein a post-processing step may include milling the tissue (paragraph [0608]; claim 17) wherein the tissue may be further milled in a frozen state to further reduce the particle size and produce flowable particulate tissue (paragraph [0648]; claim 17) wherein the tissue and fluid may be packaged in a syringe for later use (paragraph [0649]) wherein the implant may be in particulate form, in the form of a slurry, injectable, and porous (paragraph [0466]) wherein a post-processing step may comprise partially drying to a water content of at least about 95 wt% (paragraph [0607]) wherein post-processing may include diluting the acellular matrix such that it has a protein concentration of about 15% w/v or less (paragraph [0613]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Huang et al. as discussed above and to make via the process of Huang et al. as discussed above an acellular porous particulate adipose tissue matrix suitable for use as dermal filler wherein the matrix is dry porous particles or is an injectable suspension thereof in carrier such as phosphate buffered saline solution (i.e., aqueous fluid) or hyaluronic acid (i.e., flowable carriers), with a reasonable expectation of success.
Regarding the claimed recitation of “derived from a porous sponge from which the particles are produced, wherein the sponge is formed form a stabilized suspension of mechanically processed adipose acellular tissue”, such is a process step, and thus claim 1 is a product-by-process claim. Claim 1 is therefore not limited to the manipulations of the recited steps, but is rather limited only to the structure implied by the steps per MPEP 2113. In the instant case, the above-noted claim recitation only implies that the particles are porous, which is already required by the claimed recitation that the particles comprise a micro-porous structure. Nevertheless, the process of Huang et al. as discussed above includes mechanical manipulation of acellular adipose tissue into particles which are resuspended in a liquid and formed into a porous or sponge-like shaped acellular tissue, and the tissue may be further milled in a frozen state to further reduce the particle size and produce flowable particulate tissue, as discussed above.
Although Huang et al. discloses that the particles may be microparticles or milliparticles as discussed above, Huang et al. does not disclose that the particles specifically have a longest dimension between about 0.05 mm and 4 mm as claimed.
Park discloses an injectable acellular filler in particulate form (abstract) wherein injectable particles may have a size of 2 mm wherein such particle size increases longevity of the graft/filler (paragraph 14 page 4).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Huang et al. and Park by making the particles in the dermal filler matrix of Huang et al. as discussed above a size of 2 mm as suggested by Park, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to increase the longevity of the filler as suggested by Park, given that Huang et al. teaches that the particles therein may be milliparticles.
Although Huang et al. discloses that the acellular tissue is particulate and is porous as discussed above, Huang et al. does not disclose that it is specifically microporous as claimed.
Barry et al. discloses injectable void filler for soft tissue augmentation (title) wherein such composition is micro-porous (abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Huang et al., Park, and Barry et al. by making the pores in the particulate dermal filler matrix of Huang et al. in view of Park as discussed above the size of micropores as suggested by Barry et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a pore size suitable for its intended use as dermal filler because Huang et al. teaches customizing the porosity thereof for its intended use, and Barry et al. teaches that micropores are a suitable size for pores in injectable soft tissue filler, and moreover art recognized suitability for an intended purpose supports a prima facie obviousness determination per MPEP 2144.07.
Regarding claims 2-3, the recitations therein are merely additional clarifications of the process step as recited in claim 1, and claims 2-3 are thus themselves product-by-process claims, and do not imply any structure in addition to the already-required porous structure.
Regarding claims 8-10, It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Huang et al. as discussed above and to make the matrix of Huang et al. in view of Park and Barry et al. as discussed above wherein a water content thereof is at least about 95 wt%, with a reasonable expectation of success. Such range of at least about 95 wt% overlaps the claimed ranges of 80-95, 90-98, and 95-98, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claims 11-12, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Huang et al. as discussed above and to make the matrix of Huang et al. in view of Park and Barry et al. as discussed above wherein the protein concentration is about 15% w/v or less, with a reasonable expectation of success. Such range of about 15% w/v or less is believed to overlap the claimed ranges of 5-15 wt% and 5-12 wt%, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I), or alternatively such ranges are so close that a prima facie case of obviousness exists per MPEP 2144.05(I)(second paragraph).
Regarding claim 14, Huang et al. discloses a carrier as hyaluronic acid, which is non-cross-linked because it is not disclosed as cross-linked.
Regarding claim 16, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize filling effectiveness of the dermal filler of Huang et al. in view of Park and Barry et al. as discussed above by varying the concentration of particulate tissue matrix therein through routine experimentation per MPEP 2144.05(II), and thus thereby necessarily varying the concentration of carrier such as hyaluronic acid therein, and thus thereby necessarily varying the volume ratio of particulate tissue matrix to hyaluronic acid, with a reasonable expectation of success.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. in view of Park and Barry et al. as applied to claims 1-14 and 16-20 above, and further in view of Tezel et al. (US 2009/0155314 A1; published 18 June 2009).
Huang et al., Park, and Barry et al. are relied upon as discussed above.
Huang et al., Park, and Barry et al. do not disclose cross-linked hyaluronic acid as in claim 15.
Tezel et al. discloses dermal filler (title) wherein carrier therein may be non-cross linked hyaluronic acid or cross-linked hyaluronic acid (claims 7-8).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Huang et al., Park, Barry et al., and Tezel et al. by substituting the cross-linked hyaluronic acid of Tezel et al. for the non-crosslinked hyaluronic acid in the dermal filler of Huang et al. in view of Park and Barry et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because Tezel et al. teaches that non-crosslinked hyaluronic acid and cross-linked hyaluronic acid are both known carriers for use in dermal fillers (i.e., equivalents known for the same purpose) and substitution of equivalents known for the same purpose is prima facie obvious per MPEP 2144.06(II).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6, 8-10, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,821,205.
Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of the ‘205 claims produce the instantly claimed particles, and the concentration ranges overlap.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
Prosecution Insights