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
Applicant’s arguments with respect to claim(s) 1-5, 7-10, and 12-29 have been considered but are moot because the new grounds of rejection (necessitated by the amendment filed 1/20/26) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Regarding the rejection of claims 8-12 as anticipated by Shah et al. (2017/0224869) it has been acknowledged that a statement pursuant 35 USC (b)(2)(C) has been provided with regards to claim 8-12.
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 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In particular claim 1 recites “non-crosslinked”. The specification only describes processes of cross-linking.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4-5, 7-8, 12-18, 20, 22-29 are rejected under 35 U.S.C. 103 as being obvious over Connor 2012/0310367.
The applied reference has a common assignee 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. 103 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); 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 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. See generally MPEP § 717.02.
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7. Regarding claims 1 and 4-5, Connor discloses a tissue product, comprising: an implant [0062], the implant comprising a construct of acellular (see abstract and [0002-0004; 0021 etc.), adipose tissue matrix including acellular adipose tissue matrix particulates (this is interpreted as the minced adipose tissue [0053]) that has been are formed into an aqueous suspension (this is interpreted as the slurry as described in [0055-0056]), wherein the aqueous suspension/slurry forms, dried, and
stabilized to form a porous acellular tissue matrix sponge via freeze-drying (see B. Production of Adipose ECM Sponge [0056]).
However Connor does not specifically state that the implant is a breast implant; non-crosslinked acellular adipose tissue matrix particulates; or that the suspension/slurry comprises 2-10% by weight solid content.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Connor and manufacture a breast prosthesis because Connor does not limit the scope as long as it is designated to a soft tissue region.
As best interpreted due to lack of written description it would have to obvious to include non-crosslinked acellular adipose tissue because Connor states that cross-linking may be controlled to produce a desired level of stability, while maintaining desired biological, mechanical, and/or structural features and by non-crosslinking would further add control to the desired level (see [0035]).
While Connor does not specifically state that the suspension/slurry comprises 2-10%, 2-5%, or 2-4% by weight solid content, it would have been obvious to modify the invention and provide this percent weight because Connor sates that adipose ECM was resuspended in water at a ratio of 50 ml of ECM and thus falls within the claimed percentage.
8. Regarding claim 7, see [0035].
9. Regarding claim 8, Connor discloses that the implant comprises adipose tissue matrix and particles as explained supra. Connor further discloses the methods of taking the adipose tissue matrix particles that has been are formed into an aqueous suspension, wherein the aqueous suspension forms, dried, and stabilized to form a porous acellular tissue matrix sponge (see as described supra B. Production of Adipose ECM Sponge [0056]), via freeze-drying [0056], having a porosity produced based on a solid content of the suspension prior to freeze-drying. See obviousness for forma a breast implant supra.
10. Regarding claims 14-16 see rational as stated supra. Connor further discloses that the products can be processed to remove some or all of the extracellular and/or intracellular lipids [0023].
11. Regarding claim 17, see [0036] “..a dehydrothermal process can be used.” Regarding claim 18 see [0042] “…using chemical crosslinking agents”. Regarding claim 20, see [0056]. Regarding claim 22 see [0057]. Regarding claim 23 and 25, see claims 7-9. Regarding claim 24 see [0056]. Regarding claim 26, see claim 1. Regarding claim 27 see claims 11-12; Regarding claim 28 see saline buffer ([0052]). Regarding claim 29 see explanation supra.
Double Patenting
12. 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.
13. Claims 1-5, 7-10, 12-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,633,521 (hereafter '521) in view of Connor 2012/0310367. . Although the claims at issue are not identical, they are not patentably distinct from each other.
Current application claim 1-5 recites:
"1. A tissue product, comprising: a breast implant, the implant comprising a construct of
acellular adipose tissue matrix including particulate acellular adipose tissue matrix that
has been formed into a suspension, dried, and stabilized to form a porous acellular
tissue matrix sponge, wherein the suspension comprises 2-10% by weight solid content.
2. The tissue product of claim 1, wherein the implant is in the form of a rounded
breast implant.
3. The tissue product of claim 1, wherein the implant is in the form of a tear-drop
shaped breast implant.
4. The tissue product of claim 1, wherein the suspension comprises 2-5% by
weight solid content.
5. The tissue product of claim 4, wherein the suspension comprises 2-4% by
weight solid content."
Patent '521 claims 14-18 recite:
14. A tissue product, comprising: a breast implant, the implant comprising a construct of
acellular adipose tissue matrix including particulate acellular adipose tissue
matrix that has been formed into a suspension, dried, and stabilized, wherein the
suspension comprises 2-4% by weight solid content, and wherein the implant
measures at least 5 cm in at least one dimension.
15. The tissue product of claim 14, wherein the implant measures at least 8 cm in at
least one dimension.
16. The tissue product of claim 14, wherein the implant is in the form of a rounded
breast implant.
17. The tissue product of claim 14, wherein the implant is in the form of a tear-drop
shaped breast implant.
18. The tissue product of claim 14, wherein the implant is produced by a process
comprising: selecting an adipose tissue; treating the tissue to remove substantially all
cellular material from the tissue; suspending the tissue in a liquid to form a suspension
with a 2-4% by weight solid content; and freezing and drying the suspension to form a
porous sponge.
19. The tissue product of claim 14, wherein the suspension is stabilized by cross-linking.
However the patent does not specifically recite a suspension comprising 2-10%,
or 2-5%. It is obvious to one having ordinary skill in the art that the limitations of the
suspension 2-4% as claimed in the paten overlaps with the applications claimed
suspension of 2-10% and is within the scope of the invention claimed by the patent.
See MPEP 2144.05 " The court found that the overlapping endpoint of the prior art
and claimed range was sufficient to support an obviousness rejection, particularly when
there was no showing of criticality of the claimed range).
Connor discloses a tissue product, comprising: an implant [0062], the implant comprising a construct of acellular (see abstract and [0002-0004; 0021 etc.), adipose tissue matrix including acellular adipose tissue matrix particulates (this is interpreted as the minced adipose tissue [0053]) that has been are formed into an aqueous suspension (this is interpreted as the slurry as described in [0055-0056]), wherein the aqueous suspension/slurry forms, dried, and stabilized to form a porous acellular tissue matrix sponge via freeze-drying (see B. Production of Adipose ECM Sponge [0056]). As best interpreted due to lack of written description it would have to obvious to include non-crosslinked acellular adipose tissue to Pat. ‘521 and Connor because Connor states that cross-linking may be controlled to produce a desired level of stability, while maintaining desired biological, mechanical, and/or structural features and by non-crosslinking would further add control to the desired level (see [0035]).
20. Regarding claim 8 Connor further teaches the methods of using an aqueous suspension (slurry) and forming the tissues sponge via freeze-drying (see supra). It would have been obvious to one having skill in the art to utilizes the methods of forming an aqueous suspension into a sponge in order to form an implant that conforms to the surrounding soft tissue.
21. Regarding the method claims 15-29, see claims patent claims 1-13 of patent
'521. Further as stated supra with respect to the claimed ranges in paragraph 7 supra. However, pat. 521 does not recite treating the tissue includes at least one processing treatment for lipid and cell removal. Connor further discloses that the products can be processed to remove some or all of the extracellular and/or intracellular lipids [0023]. It would have been obvious to modify pat. ‘521 and remove some or all of the extracellular and/or intracellular lipids in order to remove unwanted cellular materials.
Allowable Subject Matter
Claims 6 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. 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:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197.
/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 May 5, 2026
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