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 of Claims
This office action is responsive to the amendment filed on 11/10/2025. As directed by the amendment: claims 1, 3, 5,11, 31-33, 37 and 39 have been amended, no additional claims have been cancelled and no new claims have been added. Thus, claims 1-3, 5, 7-9, 11, 12, 31-41 are presently pending in this application, and currently examined in the Office Action.
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 9, 32 and 37-40 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.
Regarding claim 9, which depends from claim 1 which sets forth the parameter of “the scaffolding construct includes a first thickness proximate to an edge portion of the scaffolding construct and a second thickness more interior relative to the edge portion, the first thickness greater than the second thickness”; and claim 9 further sets forth the parameter of “the second thickness of the scaffolding construct varies”, however, this parameter of claim 9 was never mentioned in the originally filed disclosure. Specifically, neither the originally filed specification, nor any of the figures, mentioned or suggested a scaffolding having a first thickness, proximate to an edge portion, and greater than a second thickness which is more interior relative to the edge portion, wherein the second thickness, which is more interior to and less than the edge portion, varies. It is noted that Applicant states, in the response dated 11/10/2025, that paragraph [0040], of the specification of the currently filed application, has support for the parameter disclosed above. Though Examiner agrees that there is support for the scaffolding construct having a first thickness along the edge/perimeter that is greater than a second thickness interior to the edge/perimeter; and also, separately that the scaffolding construct can have a varying thickness. However, nowhere in the originally filed disclosure has it ever been mentioned, or suggested that the scaffolding construct has a first thickness, proximate to an edge portion, greater than a second thickness, which is more interior, and also the second thickness varies.
Regarding claim 32, which sets forth the parameter of “the second biocompatible material comprises polyurethane, polyurethane/urea, poly(glycolic acid), poly(lactic acid), poly(lactic-co- glycolic acid), polycaprolactone, agarose, alginate, chitosan, collagen, fibrin, gelatin, hyaluronic acid, gelatin methacryloyl, polyethylene glycol, or a mixture thereof” (emphasis added); however this parameter was never mentioned in the originally filed disclosure. Specifically, nowhere in the originally filed specification is it ever mentioned that the second biocompatible material (which is injected within the porous structure of the scaffolding construct, according to claim 31 from which claim 32 depends) comprises the materials listed above. In order to overcome this rejection it is suggested that the word “second” be deleted and replaced with the word “first”, such that the parameter sets forth “the first biocompatible material comprises polyurethane…”.
Regarding claim 37, which sets forth the parameters of “the first thickness extends continuously along the edge portion of the scaffolding construct” (emphasis added), on lines 11-12, and “at least one of the first thickness or the second thickness has a thickness ranging from about 1mm to about 50 mm”, on the 3rd to last – 2nd to last lines; however, these parameters were never mentioned in the originally filed disclosure. Specifically, neither the originally filed specification, nor any of the figures, mentioned or suggested the first thickness extends "continuously" along the edge portion of the scaffolding construct, nor is it mentioned or suggested that at least one of the first thickness or the second thickness has a thickness ranging from about 1 mm to about 50 mm (it is to be noted that the originally filed specification does state that the overall thickness of the scaffolding construct can be in the range of about 1 mm to about 50 mm, but never specifically discloses the first thickness being in the range of 1mm to about 50 mm and/or the second thicknesses being in the range of 1 mm to about 50 mm, which is what is currently claimed).
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.
Claims 37-40 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. Independent claim 37 sets forth the parameter of “injecting a second biocompatible material into the scaffold construct”, on the last line of the claim; however, this parameter is found to be confusing since it is not clear what exactly is meant by the second biocompatible material being injected “into” the scaffold construct. Specifically, it is not clear if “into” means the second biocompatible material is injected into the pores of the scaffold construct, or the cavity of the scaffold construct, or directly into the biocompatible material of the scaffold construct. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such currently pending claims 1-3, 5, 7-9, 11, 12 and 41, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
It is further to be noted that the claimed invention of independent claim 1 is “A scaffolding construct” and the claimed invention of independent claim 37 is “A method of manufacturing a scaffolding construct”; only the claimed structural limitaons directed toward the claimed invention, i.e. the scaffolding construct hold patentable weight. Limitaons directed toward other structures/devices, i.e. a medical/breast implant and/or material injected into a cavity of the claimed scaffolding construct, are considered to the extent that they further define the final structure of the claimed invention, i.e. the scaffolding construct.
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 1-3, 5-9, 11, 12 and 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Limem et al. (US PG Pub. 2020/0100892), as previously presented, hereinafter Limem, in view of Gingras et al. (US PG Pub. 2009/0216338), as previously presented, hereinafter Gingras.
Regarding claims 1-3, 5, 7, 9 and 41, Limem discloses a scaffolding construct, for example illustrated in Figure 10, comprising a first biocompatible material that comprises a polymer/copolymer, specifically polyurethane, poly(glycolic acid), poly(lactic acid), poly(lactic-co-glycolic acid), polycaprolactone, or a mixture thereof, or a hydrogel, specifically chitosan, polyethylene glycol or a mixture thereof; wherein the scaffolding construct is porous, at least partially bioresorbable, and defines a cavity for securing a medical implant therein, the scaffolding construct is configured to partially expose the medical implant, the scaffolding construct has a circular/pita pocket-like shape with an open end (520) and a closed end (510), illustrated in Figure 10 ([0083]; [0116]; [0193] & [0193]); and a second biocompatible material embedded within a plurality of pores and/or disposed within the cavity between the medical implant and the scaffolding construct, wherein the secondary material comprises a natural filler, a synthetic filler, hyaluronic acid, collagen, or a combination thereof ([0123] & [0128]); and wherein the scaffolding construct has an average pore size less than 50mm, specifically about 10mm to about 30mm ([0097]; [0144], Line 20 & [0156], Lines 1-3); wherein the scaffolding construct includes a first thickness proximate to an edge portion of the scaffolding construct and a second thickness more interior relative to the edge portion, wherein the second thickness of the scaffolding construct varies ([0110]); but does not specifically disclose the first thickness is greater than the second thickness.
However, Gingras teaches a scaffolding construct/implant, in the same field of endeavor, wherein a periphery of the scaffolding construct/implant can be reinforced/thicker to facilitate implantation and suture retention ([0020], Last 3 Lines & [0025]).
In view of the teachings of Gingras, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first thickness, of the scaffolding construct of Limem, to be greater than the second thickness, in order to facilitate implantation and suture retention, as taught by Gingras.
Regarding claim 8, Limem in view of Gingras disclose the scaffolding construct of claim 1, wherein Limem further teaches the scaffolding construct has a thickness ranging from about 1mm to about 50mm (Limem: [0109]).
Regarding claim 11, Limem in view of Gingras disclose the scaffolding construct of claim 1, wherein Limem further teaches the scaffolding construct comprises sutures that attaches the edge portion of the scaffolding construct together to form the cavity (Limem: [0198], Lines 10-17]).
Regarding claim 12, Limem in view of Gingras disclose the scaffolding construct of claim 1, wherein Limem further teaches the cavity contains a breast implant, and a portion of an outer surface of the breast implant is uncovered by the scaffolding construct, the outer surface having a surface texture (Limem: [0154]).
Regarding claims 37, 38 and 40, Limem discloses a method of manufacturing a scaffolding construct comprising molding or bioprinting a biocompatible material, specifically polyurethane, poly(glycolic acid), poly(lactic acid), poly(lactic-co-glycolic acid), polycaprolactone, chitosan, polyethylene glycol, or a mixture thereof, to form a three-dimensional shape including a cavity formed from the scaffolding construct, forming the scaffolding construct to partially expose an implant; wherein the scaffolding construct is porous and at least partially bioresorbable, example illustrated in Figure 10 ([0083]; [0116]; [0160]; [0166]; [0193] & [0193]); wherein the scaffolding construct has an average pore size less than 50mm and/or at least one of the first thickness or the second thickness has a thickness ranging from about 1mm to about 50mm ([0097]; [0109]; [0144], Line 20 & [0156], Lines 1-3); coating/injecting a second biocompatible material, specifically fat, into the scaffolding construct ([0198], Last 5 Lines); but does not specifically disclose a first thickness, extending continuously along an edge portion of the scaffolding construct, being greater than a second thickness positioned more interior relative to the edge portion of the scaffolding construct.
However, Gingras teaches a scaffolding construct/implant, in the same field of endeavor, wherein a periphery of the scaffolding construct/implant can be reinforced/thicker to facilitate implantation and suture retention ([0020], Last 3 Lines & [0025]).
In view of the teachings of Gingras, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for a first thickness, extending continuously along an edge portion of the scaffolding construct of Limem, to be greater than a second thickness positioned more interior relative to the edge portion, in order to facilitate implantation and suture retention, as taught by Gingras.
Regarding claim 39, Limem in view of Gingras disclose the method of claim 37, wherein Limem further teaches attaching/suturing the edge portions of the scaffolding construct together to form a cavity (Limem: [0198], Lines 10-17]).
Allowable Subject Matter
Claims 31 and 33-36 are allowed.
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive. Applicant argues the rejections of claims 1 and 37 as being unpatentable over the prior art of Limem in view of Gingras, stating that Limem doesn’t teaches the newly added parameter of “the scaffolding construct is configured to partially expose the medial implant”. Examiner respectfully disagrees with Applicant’s assertion. Though Figure 1, as used in Applicant’s argument, may not expose the medial implant (though it is not specifically disclosed by Limem if the slit is completely closed/sealed or remains slightly open), there are multiple different embodiments/shapes disclosed for the scaffolding construct of Limem. For example the embodiment in Figure 10 would read on the above mentioned parameter; specifically the shape of scaffolding construct (500) is described as a pita pocket-like shape and has an opening (520) which allows a medical implant (502) to partially be exposed ([0196]). Thus, the rejections of independent claims 1 and 37, and those claims that depend from them, are deemed to be proper since Limem in view of Gingras teach all the structural limitations set forth in the claims; thus, the rejections stand.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 01/26/2026