DETAILED ACTION
The following is a non-final office action is response to communications received on 03/02/2023. Claims 1-19 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 .
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.
Claims 5, 8 & 12-19 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.
Claims 5 & 8, state a “good toughness” in lines 3 and 4 respectively. The term good is indefinite, as it is subjective and the specification provides no clear and reasonable definition as to what a good toughness comprises.
Claim 12 recites the limitation "the composite membrane" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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) 1-7 & 10-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiles (US 7,795,027).
PNG
media_image1.png
462
458
media_image1.png
Greyscale
Regarding Claim 1, Hiles teaches a composite decellularized matrix membrane (10), comprising a decellularized matrix (Col 3: lines 54-58) membrane (12, 16; Col 12: lines 30-38) and a polymer membrane (14; Col 12: lines 50-59), wherein the composite decellularized matrix membrane comprises two layers of the decellularized matrix membranes 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).
Regarding Claim 2, Hiles teaches wherein the decellularized matrix membrane is prepared from a biomaterial of a porcine (Col 12: lines 34-39 & Col 4: lines 7-17) small intestine, a porcine bladder, and porcine skin.
Regarding Claim 3, Hiles teaches wherein the polymer membrane is prepared from a polymer material of polycaprolactone, polylactic acid, and polyurethane (Col 12: line 59 – Col 13: line 2).
Regarding Claim 4, Hiles teaches wherein the decellularized matrix membrane is 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 good-toughness 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 13-17, Hiles teaches the device as set forth in the rejections of claims 2-7.
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).
PNG
media_image2.png
746
488
media_image2.png
Greyscale
Regarding Claim 1, Brown teaches a composite decellularized matrix membrane (310), comprising a decellularized [0008] matrix membrane (312) and a polymer [0027] membrane (314), wherein the composite decellularized matrix membrane comprises two layers of the decellularized matrix membranes and one layer of the polymer membrane (Fig 5), and the one layer of the polymer membrane is located between the two layers of the decellularized matrix membranes (Fig 5).
Regarding Claim 2, Brown teaches wherein the decellularized matrix membrane is prepared from a biomaterial of a porcine small intestine, a porcine bladder, and porcine skin [0008].
Regarding Claim 4, Brown teaches wherein the decellularized matrix membrane is prepared from a submucosa of a porcine small intestine [0005].
Regarding Claims 8 & 9, as best understood (see 112 rejection), 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 with a good toughness and capable of preventing inflammation.
Conclusion
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.
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.
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774