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 .
Claim Status
Applicant’s submission filed 11/24/2025 has been received and entered. Claims 1, 3-6, 8-10 and 14-17 have been amended. Claims 31 and 32 have been new added. Claims 15, 16 and 29 are remain withdrawn with traverse, as being directed to un-elected inventions. Accordingly, claims 1, 3-6, 8-10, 14, 17, 21-25 and 31-32 are pending and under current examination.
Status of Prior Rejection/Response to Arguments
The rejection to claims 1 and 3-6 under 35 U.S.C. 103 over Guo et al. in view of Mendoza-Novelo et al. and Guo 2013 is withdrawn:
The rejection to claims 1, 3-6 and 8 under 35 U.S.C. 103 over Guo et al. in view of Mendoza-Novelo et al., Guo 2013 and Van Den Bulcke et al. is withdrawn:
The rejection to claims 1, 3-6, 9, 10, 14, 17 and 21-25 under 35 U.S.C. 103 over Guo et al. in view of Mendoza-Novelo et al., Guo 2013, Wang et al. and Shavandi et al. is withdrawn:
Applicant amends claims 1, 3-6, 8-10, 14 and 17, asserts that: 1) the claimed "re-flattenable" property is not disclosed or suggested by the prior art; 2) the use of fresh, non-decellularized tissue is distinctive; 3) SPMA distribution via physical permeation and formation of an interpenetrating network (IPN) are not disclosed by the prior art; 4) the combination of technical features is non-obvious; 5) synergistic effect of technical features of claim 1 is unexpected (Remarks, p7-11).
Applicant’s argument is found persuasive. Specifically, Applicant’s amendment to claims limit the biological matrix material is a fresh animal tissue obtained from swine, ovine or bovine, without decellularization treatment, this limitation overcomes the rejections on record. The primary reference Guo et al. require the step of decellularization (see p45, right column), Mendoza-Novelo et al. teach three decellularization agents for bovine pericardium to preserve the collagen structural network, anisotropy and the tensile modulus, tensile strength and maximum strain at failure of native tissue (see abstract). None of the prior arts teach or suggest the method using a fresh animal tissue without decellularization. Therefore the rejection is withdrawn.
Regarding claim 17, Applicant deletes the limitation “wherein step a comprises decellularizing the animal pericardium material” to show that the claimed method does not require decellularization treatment. However, Applicant is reminded that claim 17 recites a method “comprising steps of”, transitional phrase “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See MPEP 2111.03. In instant case, deleting the limitation is not sufficient to show the claimed method does not require decellularization treatment. Applicant is recommended to amend the limitation “wherein step a comprises decellularizing the animal pericardium material” to “wherein the animal pericardium material obtained from step a is a material without decellularization treatment” to differentiate instant claims to the prior arts.
New grounds of rejections are necessitated by Applicant’s amendment.
New Claim Objections
Claim 1 is newly objected to because of the following informalities: Claim 1 recites “without decellularized treatment”, it needs to be “decellularization treatment”. Appropriate correction is required.
New Claim Rejections - 35 USC § 112(a)
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, 3-6, 8-10, 14 and 31-32 are newly 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.
Claims 1, 3-6, 8-10, 14 and 31-32 recite the term “re-flattenable”, which is interpreted as the biological matrix material was flat to begin with, became un-flat and then flattened. However, paragraph [0008] recites “the dry film being released can quickly absorb water and recover to be flattened in the human environment“, which means the film can be flattened following water absorption. There is no mention of the steps of “flat” to “un-flat”. Applicant is recommended to amend the term “re-flattenable” to “flattenable” to obviate the current rejection on record.
Claim 31 recites “an interpenetrating network is formed between the biomaterial and polymer”. Applicant states that support of this limitation is in the paragraph [0133] of specification (Remarks, p6), which recites “[t]he method in Example 1 can effectively protect elastin in the decellularized matrix, potentially improving the mechanical properties and prolonging the service life thereof. This is because the density of crosslinks is improved by an interpenetrating network of the biomaterial prepared according to the method of the present invention with the polymer, thereby protecting the elastin”, indicates the limitation is under the condition of decellularization treatment, while claim 31 limits the condition is “without decellularization treatment”, therefore specification paragraph [0133] fails to provide support to the limitation in claim 31.
This is a new matter rejection as necessitated by Applicant’s amendment.
New Claim Rejections - 35 USC § 112(b)
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 17, 21-25 and 31 are newly 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. The rejection is as necessitated by Applicant’s amendment.
Claim 17 recites the limitation "the biological matrix material" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
Claims 21-25 depend from claim 17, and thus inherit the deficiency and are rejected on the same basis.
Claim 31 recites the limitation "the biomaterial and polymer" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Related Prior Art
As stated above, Guo et al. is considered as the closet prior art. Applicant’s amendment to the claims overcomes the obviousness rejection on record. The claimed method in instant application is considered free of the prior art.
Conclusion
No claims are allowed.
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.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699