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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 3/5/26 are acknowledged.
37 CFR 1.121 (c)(4)(i) states that no claim text should be presented for a canceled claim. Although strikethrough claim text has been provided for canceled claims of the 3/5/26 claim set, the claim set has been entered and considered.
Any objection or rejection from the 1/14/26 office action that is not addressed below is withdrawn based on the amendments.
Previously, the species of RADA16 (SEQ ID NO:1) was elected.
Claims 2-5, 7 and 9 have been canceled.
Claims 1, 6 and 8 are being examined.
Priority
The priority information is found in the filing receipt dated 7/19/23.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/5/26 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The rejection of claim 8 is maintained from the previous office action.
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 8 is 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 term “atraumatically” in claim 8 is a relative term which renders the claim indefinite. The term “atraumatically” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although not defined, the term atraumatically is often described in terms of ‘minimal’ injury which requires a subjective determination. It is unclear how to distinguish traumatic from atraumatic in the context of the instant claim.
Response to Arguments - 112
Applicant's arguments filed 3/5/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that ‘atraumatic’ has an entry in a dictionary, the mere entry in a dictionary does not mean that the scope of the claim is clear in the context of that word. Further, there is no indication in the specification that the term is limited to that specific definition. The term “atraumatically” in claim 8 is a relative term which renders the claim indefinite. The term “atraumatically” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although not defined, the term atraumatically is often described in terms of ‘minimal’ injury which requires a subjective determination. It is unclear how to distinguish traumatic from atraumatic in the context of the instant claim.
Claim Rejections - 35 USC § 103
Claims were rejected previously under 103 based on the references cited below. Since the claims have been amended the rejection is updated to correspond to the instant claims.
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 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.
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.
Claim(s) 1, 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (NPL citation 20 of IDS 8/27/23; ‘Lee’) in view of Subramaniam et al. (NPL citation 35 of IDS 8/27/23; ‘Subramaniam’).
Lee teach a haemostatic agent based on a self assembling peptide in the setting of nasal endoscopic surgery (title). Lee teach that patients experienced endonasal turbinoplasty (abstract). Lee teach the use of PuraStat to reduce bleeding specifically after turbinate tissue resection (section 2.7 and figure 2). Lee teach that PuraStat is a peptide solution of RADA16 that forms a colorless hydrogel (section 2.6 first paragraph and figure 1). Lee teach that 2.5% of the peptide solution was used (section 2.6 paragraph 3). Lee teach the use of a syringe for administration at the bleeding point (sections 2.6-2.7 specifically last paragraph of section 2.7). Lee teach that the results are such that PuraStat is well suited for use in endonasal surgery (section 5). Lee teach that no re-bleeding was noted at 4 weeks and visual inspection showed normal healing (pages 462-463 connecting paragraph).
Lee does not recite the use of a catheter to apply the composition.
Lee recognizes a need to cover the posterior end of the turbinate and suggest the use of longer nozzles (section 2.7 paragraph 2) and shows a surface for application (figure 2).
Subramaniam teach endoscopic procedures (title and abstract) specifically those that use PuraStat (page 29 4th paragraph). Subramaniam specifically teach the use of a catheter to apply Purastat (page 29 4th paragraph and figure 1). Subramaniam teach that PuraStat is an effective hemostat (abstract conclusion section).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Lee based on the suggestion of Lee. Lee teach the use of a syringe for administration at the bleeding point (sections 2.6-2.7) and shows a surface for application (figure 2). Lee recognizes a need to cover the posterior end of the turbinate and suggest the use of longer nozzles (section 2.7 paragraph 2). Since Subramaniam teach endoscopic procedures (title and abstract) specifically those that use PuraStat (page 29 4th paragraph) one would have been motivated to use the teachings and suggestions of Subramaniam. Subramaniam specifically teach the use of a catheter to apply Purastat (page 29 4th paragraph and figure 1). One would have been motivated to apply via the catheter for ease of use and to cover the posterior end of the turbinate. One would have had a reasonable expectation of success since Lee teach that the results are such that PuraStat is well suited for use in endonasal surgery (section 5). Lee teach that no re-bleeding was noted at 4 weeks and visual inspection showed normal healing (pages 462-463 connecting paragraph). Subramaniam teach that PuraStat is an effective hemostat (abstract conclusion section).
In relation to the subject of claim 1, Lee teach a haemostatic agent based on a self assembling peptide in the setting of nasal endoscopic surgery (title). Lee teach that patients experienced endonasal turbinoplasty (abstract).
In relation to the peptide of claim 1, Lee teach the use of PuraStat to reduce bleeding (section 2.7 and figure 2). Lee teach that PuraStat is a peptide solution of RADA16 that forms a colorless hydrogel (section 2.6 first paragraph and figure 1). RADA16 is instant SEQ ID NO:1 and the elected species. Lee teach that 2.5% of the peptide (RADA16, instant SEQ ID NO:1) solution was used (section 2.6 paragraph 3). Lee teach that PuraStat is a licensed haemostatic product (pages 463-464 connecting paragraph) and was provided by a vendor (section 2.6). Since PuraStat is a licensed haemostatic product (pages 463-464 connecting paragraph) and was provided by a vendor (section 2.6) it would have been provided in a purified form (applicants own example also uses a product from the same vendor page 18).
In relation to the catheter of claim 1, Subramaniam specifically teach the use of a catheter to apply Purastat (page 29 4th paragraph and figure 1).
In relation to any outcomes or intended uses as recited in claim 1, Lee teach the use of PuraStat to reduce bleeding (section 2.7 and figure 2). Lee teach that PuraStat is a peptide solution of RADA16 that forms a colorless hydrogel (section 2.6 first paragraph and figure 1) which is the elected species. Since the prior art teach the claimed agent it would function as claimed. Further, Lee teach inspection showed the absence of any adhesion formation in all the patients and visual inspection showed normal healing (pages 462-463 connecting paragraph).
In relation to claim 6, Lee specifically teach an endonasal application (section 2.7).
In relation to claim 8 , Lee teach normal healing (pages 462-463 connecting paragraph).
Response to Arguments - 103
Applicant's arguments filed 3/5/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue Subramaniam is not relevant to the claims as amended, applicants themselves acknowledge that claim 1 refers to application via a catheter. All of the dependent claims incorporate the limitation of application via a catheter. Subramaniam teach endoscopic procedures (title and abstract) specifically those that use PuraStat (page 29 4th paragraph). Subramaniam specifically teach the use of a catheter to apply Purastat (page 29 4th paragraph and figure 1). Subramaniam teach that PuraStat is an effective hemostat (abstract conclusion section). Thus, Subramaniam is relevant for the administration of PuraStat. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants argue that the claims have been amended, the amended claims are addressed above. With respect to the peptide, Lee teach the use of PuraStat to reduce bleeding (section 2.7 and figure 2). Lee teach that PuraStat is a peptide solution of RADA16 that forms a colorless hydrogel (section 2.6 first paragraph and figure 1). RADA16 is instant SEQ ID NO:1 and the elected species. Lee teach that 2.5% of the peptide (RADA16, instant SEQ ID NO:1) solution was used (section 2.6 paragraph 3). Lee teach that PuraStat is a licensed haemostatic product (pages 463-464 connecting paragraph) and was provided by a vendor (section 2.6). Since PuraStat is a licensed haemostatic product (pages 463-464 connecting paragraph) and was provided by a vendor (section 2.6) it would have been provided in a purified form (applicants own example also uses a product from the same vendor page 18).
Although applicants argue about claim 6 and a thereby clause, the active step of claim 6 is applying. MPEP 2111.04 recognizes that a whereby clause in a method claim is not given weight when it simply expressed the intended result of a process step positively recited. Lee specifically teach an endonasal application (section 2.7). Figure 3 shows (in the video) administration through the nostril (which is a sinus orifice). Since a claimed agent is suggested to be administered as claimed it would function as claimed.
Conclusion
Applicant's amendment necessitated any 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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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