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
This action is in response to papers filed January 15, 2026. Applicant’s reply to the restriction/election requirement of November 20, 2025 has been entered. Claims 1-19 are pending in the application.
Election/Restrictions
Applicant’s election of Group I, claims 1-6, is acknowledged. Applicant’s elections of i) “starch glycolate” as the species of crosslinked polysaccharide, ii) “non-woven” as the species of woven state of the cellulosic polymer, iii) “hemostasis” as the species of what the method of use must achieve, iv) “the powder of claim 1” as the species of the composition that must be applied in the method to achieve hemostasis or tissue sealing, and v) “dissolving the aldehyde functionalized component in a solution of CHES” as the species of the order of combining the aldehyde functionalized component and CHES are all also acknowledged. The Examiner has determined that claims 1-6 read on the elected subject matter.
Accordingly, claims 7-19 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Election was made without traverse in the reply filed on January 15, 2026. Claims 1-6 are currently under examination.
Drawings
The drawings are objected to because of the following:
1. The figure is not in compliance with 37 CFR 1.84 (u)(1), which states, in part, that “where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1-6 are objected to because of the following:
i) In claims 1 and 2, the preamble should have a comma between “flowable” and “tissue adhesive”; and there should be a dash between “tissue” and “adhesive”. It is further noted that the preamble of claims 3-6 is different, as “tissue adhesive” has been removed.
ii) In claims 2-6, the preamble should begin with “The flowable”, not “A flowable”.
iii) Claim 2 is in improper Markush format. Applicant is advised that a proper Markush claim has the general format “selected from the group consisting of A, B, and C”, not “selected from the group consisting of A and B and C”.
iv) In claim 3, the expression “the polysaccharide are” is in improper English grammatical form.
Appropriate correction is required.
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 1-6 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.
Claim 1 is indefinite for the following reasons:
1. Claim 1 is directed to a flowable “powder material” that comprises the recited constituents. A “powder material” appears to be broader in scope and more nuanced that simply a “powder”. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of a “powder material”. For example, is a “powder material” limited exclusively to a powder only, i.e. the claimed composition as a whole is necessarily a powder? Or, rather, can a “powder material” be in the form of e.g. a liquid suspension, or e.g. a paste, which contains as a constituent element therein a powder, such as the crosslinked polysaccharide powder element of (a)? Or, alternatively, can a “powder material” be in any form, e.g. a liquid, or e.g. a solid block, that can be made into a powder, i.e. by physical or chemical means?
2. Claim 1 requires that the composition contains “crosslinked polysaccharides”, and it is noted that in dependent claims, the crosslinked polysaccharide is specifically e.g. starch glycolate, but then stipulates that the polysaccharide must undergo a chemical reaction, specifically an oxidation, to convert at least a portion of the anhydroglucose units to aldehydes. It would appear that if the polysaccharide, such as starch glycolate, undergoes a chemical reaction, the product is no longer a polysaccharide, e.g. no longer starch glycolate, but rather a different chemical compound. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 2-6 are indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Miksa et al. (U.S. Patent Application Pub. No. 2007/0104660), in view of Wang et al. (U.S. Patent Application Pub. No. 2018/0117019), and Laas et al. (U.S. Patent Application Pub. No. 2020/0352982).
Applicant Claims
Applicant’s elected subject matter is directed to a flowable “powder material” comprising starch glycolate, in which at least a portion of the anhydroglucose units have been oxidized to form aldehydes, and a zwitterionic buffer; wherein the said oxidation reaction is via a periodate salt.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Miksa et al. disclose a composition that can be in the form of a powder or a “powder material” comprising i) particles containing bioadhesive polymers, and ii) a buffer to maintain pH within 4.5-10; wherein the bioadhesive polymer can be e.g. a carboxymethyl starch, and wherein the bioadhesive polymer can be oxidized by e.g. a periodate salt to form e.g. aldehyde (i.e. carbonyl) functional groups (abstract; paragraphs 0010, 0021, 0022, 0038, 0039, 0043, 0044, 0055, 0056, 0060, 0063, 0064, 0069).
Wang et al. disclose a composition that can be in the form of a powder or a “powder material” comprising e.g. a bioadhesive polymer, and that can further comprise e.g. a buffer to maintain pH within 3-9; wherein the bioadhesive polymer can be sodium starch glycolate (i.e. a crosslinked carboxymethyl starch), and the buffer can be e.g. a TRIS buffer (i.e. a zwitterionic buffer) (see e.g. 0013, 0029, 0030, 0032).
Laas et al. disclose a composition that can be in the form of e.g. a powder comprising sodium starch glycolate, wherein the particles comprising sodium starch glycolate are in the form of a fine, flowable powder (see e.g. abstract; paragraphs 0016, 0052)
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Miksa et al. do not explicitly disclose that the polysaccharide is sodium starch glycolate, that the buffer is a zwitterionic buffer, and that the powder is “flowable”. These deficiencies are cured by the teachings of Wang et al. and Laas et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Miksa et al., Wang et al., and Laas et al., outlined supra, to devise the claimed composition.
Miksa et al. disclose a composition that can be in the form of a powder or a “powder material” comprising i) particles containing bioadhesive polymers, and ii) a buffer to maintain pH within 4.5-10; wherein the bioadhesive polymer can be e.g. a carboxymethyl starch, wherein the bioadhesive polymer can be oxidized by e.g. a periodate salt to form e.g. aldehyde (i.e. carbonyl) functional groups, and wherein the composition is intended for application in tissue adhesion. Since Wang et al. disclose that for a composition intended for tissue adhesion, which can be in the form of a powder or a “powder material”, sodium starch glycolate (i.e. a crosslinked carboxymethyl starch) is a suitable bioadhesive polymer, and a TRIS buffer (i.e. a zwitterionic buffer) is a suitable buffer for maintaining the pH within 3-9; and since Laas et al. disclose that a powder comprising sodium starch glycolate can be in the form of a fine, flowable powder; one of ordinary skill in the art would thus be motivated to employ starch glycolate as the bioadhesive polymer, and a TRIS buffer as the buffer in the Miksa et al. composition, with the reasonable expectation that the resulting powder comprising sodium starch glycolate will be “flowable” and that the resulting composition will successfully adhere to tissues.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617