DETAILED ACTION
The following is a final office action is response to communications received on 04/30/2026. Claims 1, 2, 4-13 & 15-19 are currently pending and addressed below.
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 filed 04/30/2026 have been fully considered but they are not persuasive.
On page 6, applicant argues that Hiles does not teach a synthetic membrane prepared from materials such as polycaprolactone (PCL), polylactic acid (PLA), or polyurethane. In contrast, Hiles teaches a composite where the intermediate layer is a biological matrix deposited by cells (e.g., fibronectin, laminin) or a substrate treated with cells (Hiles Col. 4, lines 10-20).
The examiner respectfully disagrees. Hiles teaches that innermost layer 12 is made of the decellularized matrix membrane (Col 12: lines 30-38). With additional layers 13-16 being made of any suitable material to provide desired reinforcement and strength (Col 12: lines 50-55). Further, one or more of layers 13-15 may be formed of a synthetic polymer such as polyurethane (Col 12: line 56-Col 13: line 2). Furthermore, one or more of layers 13-16 are formed from additional decellularized matrix membrane (Col 13: lines 3-10) to provide strength to the construct (Col 13: lines 25-18). Therefore, Hiles teaches an inner layer (12) of decellularized matrix, an intermediate layer of polymer (13-15), and an outermost layer (16) of decellularized matrix to provide strength to the construct.
On page 6, applicant argues that Hiles fails to teach a dense membrane of PCL, PLA, or PU as a distinct, pre-formed layer.
The examiner respectfully disagrees. As discussed supra, Hiles teaches the claimed polymers. Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., dense membrane and distinct and pre-formed membrane) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On page 7, applicant argues that Brown teaches a bioprosthetic device comprising layers of small intestine submucosa (SIS) and a synthetic foam or a three-dimensional mesh. The applicant argues that, due to its mesh/textile nature, that Brown’s synthetic layer, is distinct from the claimed polymer membrane.
The examiner respectfully disagrees. The American Heritage Dictionary defines a membrane as (1) a thin, pliable layer of natural or synthetic material; or (2) a thin sheet of natural or synthetic material that is permeable to substances in solution. The examiner believes that the cited polymer layer of Brown (314) is a reasonable interpretation of the claimed language.
The Examiner notes the updated rejection was necessitated by the Applicant’s amendments.
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 15-17 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 15 depends on cancelled claim 14. For examination purposes, the examiner assumes claim 15 should depend on claim 13. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 18 & 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 17 & 18 require wherein the polymer membrane is prepared from at least a polymer material of polydimethylsiloxane, polyurethane, polylactic acid-glycolic acid, polyvinyl alcohol, and polyhydroxy fatty acid ester. Claim 18 requires wherein the polymer membrane is prepared from polydimethylsiloxane. Amended claim 12 require wherein the polymer membrane is prepared from polycaprolactone, polylactic acid, and polyurethane.
The polydimethylsiloxane recited in claims 17 & 18 is neither a polycaprolactone, polylactic acid, or a polyurethane and therefore does not further limit the subject matter of claim 12 .
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4-7, 10-13 & 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiles (US 7,795,027).
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Regarding Claim 1, Hiles teaches a composite decellularized matrix membrane (10), comprising two layers of the decellularized matrix (Col 3: lines 54-58) membranes (12, 16; Col 12: lines 30-38) and one layer of the polymer membrane (Fig 2), and the one layer of the polymer membrane is located between the two layers of the decellularized matrix membranes (Fig 2), wherein the polymer membrane is prepared from polycaprolactone, polylactic acid, and polyurethane (Col 12: line 59 – Col 13: line 2).
Regarding Claim 2, Hiles teaches wherein the decellularized matrix membranes are prepared from a porcine (Col 12: lines 34-39 & Col 4: lines 7-17) small intestine, a porcine bladder, or porcine skin.
Regarding Claim 4, Hiles teaches wherein the decellularized matrix membranes are prepared from a submucosa of a porcine small intestine (Col 12: lines 30-38).
Regarding Claim 5, as best understood (see 112 rejection), Hiles teaches wherein the polymer membrane is prepared from polycaprolactone (Col 12: line 59 – Col 13: line 2) and the composite membrane is usable (fully capable of) for preparing an absorbably degradable and tough artificial bladder (Col 11: lines 20-24) capable of preventing calculi, water infiltration, and inflammation.
Regarding Claim 6, Hiles teaches wherein the polymer membrane is prepared from polylactic acid (Col 12: line 59 – Col 13: line 2)and the composite membrane is usable (fully capable of) for preparing an absorbably degradable artificial bladder (Col 11: lines 20-24) capable of preventing calculi and water infiltration.
Regarding Claim 7, Hiles teaches wherein the polymer membrane is prepared from polyurethane (Col 12: line 59 – Col 13: line 2).
Regarding Claim 10, only the product will be examined. (Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)); see MPEP 2113). To the extent that the process steps further define the structure of the device, they have been considered. In the instant case, none of the process steps recited in claim 10 further define or add any structural limitations to the component.
Regarding Claim 11, only the product will be examined. (Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)); see MPEP 2113). To the extent that the process steps further define the structure of the device, they have been considered. In the instant case, none of the process steps recited in claim 11 further define or add any structural limitations to the component.
Regarding Claim 12, Hiles teaches the composite as set forth in the rejection of claim 1. Further, Hiles teaches wherein the composite is an artificial bladder.
Regarding Claims 13, Hiles teaches wherein the decellularized matrix membranes are prepared from a porcine (Col 12: lines 34-39 & Col 4: lines 7-17) small intestine, a porcine bladder, or porcine skin.
Regarding Claims 15, Hiles teaches wherein the decellularized matrix membranes are prepared from a submucosa of a porcine (Col 12: lines 34-39 & Col 4: lines 7-17) small intestine.
Regarding Claims 16, Hiles teaches wherein the polymer membrane is prepared from polycaprolactone (Col 12: line 59 – Col 13: line 2).
Regarding Claims 17, Hiles teaches wherein the polymer membrane is prepared from polyurethane (Col 12: line 59 – Col 13: line 2).
Claim(s) 1, 2, 4, 8 & 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown (US 2003/0023316).
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Regarding Claim 1, Brown teaches a composite decellularized matrix membrane (310), comprising two layers of decellularized [0008] matrix membranes (312) and one layer of a polymer [0027] membrane (314), and the one layer of the polymer membrane is located between the two layers of the decellularized matrix membranes (Fig 5), wherein the polymer membrane is prepared from polycaprolactone, polylactic acid, or polyurethane [0019].
Regarding Claim 2, Brown teaches wherein the decellularized matrix membranes are prepared from a porcine small intestine, a porcine bladder, and porcine skin [0008].
Regarding Claim 4, Brown teaches wherein the decellularized matrix membranes are prepared from a submucosa of a porcine small intestine [0005].
Regarding Claims 8 & 9, Brown teaches wherein the polymer membrane is prepared from at least one polymer material of polydimethylsiloxane, polylactic acid-glycolic acid, polyvinyl alcohol [0027], and polyhydroxy fatty acid ester, and wherein the composite membrane is usable (fully capable of) for preparing an artificial bladder which is tough and capable of preventing inflammation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matheny (US 10,512,711) teaches an artificial bladder (Col 2: lines 21-26), wherein the artificial bladder comprises a composite decellularized matrix membrane (Fig 1C), the composite decellularized matrix membrane comprises two layers of decellularized matrix membranes and one layer of a polymer membrane (Fig 1C), and the one layer of the polymer membrane is located between the two layers of the decellularized matrix membranes (Fig 1C and Col 2: lines 10-13); wherein the polymer membrane is prepared from polycaprolactone, polylactic acid, or polyurethane (Col 4: lines 3-16).
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 BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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