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 .
Detailed Action
Status of Application
1. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, filed 18 March 2026, and the Amendment and Applicants’ Arguments/Remarks, all filed 27 February 2026 are acknowledged.
Claims 1-3, 6-31, and 34-41 are currently pending. Claims 4-5 and 32-33 have been cancelled. Claims 1, 11-12, and 20 have been amended. Claims 39-41 are newly added. Claims 1-3, 6-31, and 34-41 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed om 18 March 2026 has been entered.
Withdrawn Rejections
3. Applicants’ arguments, filed 18 March 2026, with respect to the 35 U.S.C. 112(a) Rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) Rejections of claims 1-3, 6-25 and 27-28 have been withdrawn in view of the interpretation of “prevent” to mean “hinder”. The 35 U.S.C. 103 Rejection over Levy et al. (U.S. Patent Application Publication No. 2014/0288641) in view of Wang et al. (ACS Appl Mater Interfaces, 2011), Rodgers et al. (U.S. Patent Application Publication No. 2017/0325949), and Frasca et al. (Abstract 16744, 2018) has been withdrawn. However, upon further consideration, a new rejection is made in view of Mero et al. (J. Controlled Release, 2008).
Examiner’s Note: Claims 26 and 29 are allowed.
Claims 2-3, 11-18, 20-29, 31, 37-38, and 40 are free of the prior art but depend from rejected claims.
Maintained Rejections
Claim Rejections – 35 U.S.C. 112(b)
4. 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.
5. Claims 1-3, 6-25, 27-28, and 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.
6. Regarding instant claims 1 and 11, the phrase “effectively preventing” is not defined by the claim nor does the specification provide a standard for ascertaining the requisite metes and bounds, thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Deletion of the word “effectively” will overcome this deficiency.
7. Regarding instant claim 20, the phrase “effectively inhibiting” is not defined by the claim nor does the specification provide a standard for ascertaining the requisite metes and bounds, thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Deletion of the word “effectively” will overcome this deficiency.
8. Regarding instant claim 27, the phrase “effectively prevent” is not defined by the claim nor does the specification provide a standard for ascertaining the requisite metes and bounds, thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Deletion of the word “effectively” will overcome this deficiency.
9. Claim 37 recites the limitation "the bioprosthetic heart valve leaflet tissue" in line 1. There is insufficient antecedent basis for this limitation in the claim.
New Rejections
Claim Rejections – 35 U.S.C. 102
10. 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.
11. Claim(s) 1, 6, 8-9, 19, 30, 35, 39, and 41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mero et al. (J. Controlled Release, 2008).
Regarding instant claims 1, 8, 19, 30, 39, and 41, Mero et al. disclose poly(2-ethyl-2-oxazoline) (POZ) conjugated to high and low molecular weight biomolecules trypsin and Ara-C. The coupling of POZ to trypsin did not affect the enzymatic activity towards low mass substrates. The POZ-protein conjugates showed hydrodynamic volumes and protein rejecting properties similar to PEG-conjugates. See abstract.
The specification does not further define the biomaterial nor attaching within the biomaterial. Thus covalently bonding to trypsin reads on attaching polyoxazoline to and within the protein based biomaterial. The active step of the claim is covalently attaching polyoxazoline to a protein based biomaterial. Since Mero et al. disclose the same active step, it should function in the same manner. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claims 6, 9, and 35, the molecular weight is 5.3 kDa. See Figure 1.
Thus the instant claims are anticipated by Mero et al.
Claim Rejections -35 U.S.C. 103
12. 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.
13. Claim(s) 1, 6-10, 19, 30, 34-36, 39, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mero et al. (J. Controlled Release, 2008) in view of Wang et al. (ACS Appl Mater Interfaces, 2011).
Mero et al. teach poly(2-ethyl-2-oxazoline) (POZ) conjugated to high and low molecular weight biomolecules trypsin and Ara-C. The coupling of POZ to trypsin did not affect the enzymatic activity towards low mass substrates. The POZ-protein conjugates showed hydrodynamic volumes and protein rejecting properties similar to PEG-conjugates. See abstract. The molecular weight is 5.3 kDa. See Figure 1.
The specification does not further define the biomaterial nor attaching within the biomaterial. Thus covalently bonding to trypsin reads on attaching polyoxazoline to and within the protein based biomaterial. The active step of the claim is covalently attaching polyoxazoline to a protein based biomaterial. Since Mero et al. teach the same active step, it should function in the same manner.
Mero et al. do not teach a MW of 10,000 Da.
Wang et al. teach that poly(2-ethyl-2-oxazoline) (PEOX) are covalently immobilized to form protein-resistant surfaces via photocoupling chemistry based on the CH insertion reaction of light-activated perfluorophenyl azide. See abstract. PEOX with average MW 5,000 and 500,000 are used. See page 3. The largest amount of bovine serum albumin was absorbed on the PEOX 5,000 and the smallest on PEOX 500,000. See abstract. The protein resistant property of the films was studied using bovine serum albumin by fluorescence imaging. See abstract.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one polyoxazoline material for another to yield predictable results because PEOX with molecular weight values of 5000 to 500000 Da are effectively covalently immobilized to form protein resistant surfaces. It would have been obvious to couple a fluorescent marker to the polyoxazoline as a commonly known technique for imaging as taught by Wang et al.
Response to Arguments
Applicant's arguments filed 27 February 2026 have been fully considered but they are not persuasive.
14. Applicants argued, “Examiner indicated that the rejections under 35 U.S.C. 112(b) were being withdrawn; this rejection is now moot.”
In response to applicants’ arguments, Examiner apologizes if there was confusion regarding the 35 U.S.C. 112(b) Rejection. Although during the interview the Examiner did indicate withdrawal of the 35 U.S.C. 112(a) Rejection regarding “preventing” and “inhibiting”, the 35 U.S.C. 112(b) Rejection is maintained because the phrase “effectively” is a relative term of degree. Since the specification does not provide a standard for ascertaining the requisite degree, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Thus this rejection is maintained.
Conclusion
15. No claims are allowed at this time.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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