DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on November 10, 2025, have been received and entered.
Claim Disposition
3. Claim 2 has been cancelled. Claims 16-20 have been added. Claims 1 and 3-20 are pending and are under examination.
Information Disclosure Statement
4. To date no Information Disclosure Statements have been filed. Applicant is reminded of the duty to disclose.
Claim objection
5. Claims 1, and 3-20 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claims 1, 4, 6, 12, 16-17 and 19 are amended to delete, “sufficient and sufficiently” in these claims. The dependent claims hereto to are also included.
Appropriate correction is required.
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.
6. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
7. Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horowitz et al. (Transfusion, vol. 24, Issue 4, July 1984, pages 357-362).
The claimed invention is directed to preparation of a method of preparing a fibronectin concentrate (see claim 16 in its entirety).
The Horowitz et al. reference teaches production of fibronectin via a preparation of antihemophilic factor (AHF) from a large pool of human plasma cryoprecipitate (see abstract and page 357). The reference teaches that human plasma cryoprecipitate is rich in both antihemophilic factor (AHF); are utilized in a pool of plasma from proteins and uses human albumin. The fibronectin is separated from contaminants and purified (see pages 357-359 and FIG 3). The reference does not per se teach irradiation to inactivate bacteria, fungi and viruses, however, the fact that they removed contaminants and filtered the fibronectin to recovery it means the same was performed.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was effectively filed to arrive at the claimed invention as a whole because the reference teaches producing fibronectin and isolating from fibrinogen and other impurities. One of ordinary skill in the art would know to filter the desired product to obtain a pure protein concentrate, thus obvious.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that a new rejection has been instituted over newly submitted claim 16 for the reasons set forth above.
Conclusion
9. No claims are presently allowable.
10. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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