DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status
Applicant’s response dated 09 June 2026 to the previous Office action dated 17 December 2025 is acknowledged. Claims 1, 3-7, 9, 11-17, 21-22, and 24-48 are pending in the application.
A new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The rejection under 35 U.S.C. 103 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new rejection under 35 U.S.C. 103 is made herein in view of applicant’s claim amendments.
The double patenting rejections made in the previous Office action are withdrawn in view of applicant’s claim amendments.
Election/Restrictions
Claims 43-44 and 46-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 14 November 2023.
Claims 1, 3-7, 9, 11-17, 21-22, 24-42, and 45 are under current consideration.
Claim Rejections - 35 USC § 112
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, 3-7, 9, 11-17, 21-22, 24-42, and 45 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 recites “a reduced compression time” but does not indicate what the compression time is reduced in comparison to, and thus it cannot be determined what compression time would fall within such recitation (i.e., infringe), thereby rendering the claim indefinite. Claims 3-7, 9, 11-17, 21-22, 24-42, and 45 are rejected as depending upon claim 1 without remedying such deficiency.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 3-7, 9, 11-17, 21-22, 24-42, and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hardy et al. (US 2011/0052665 A1; published 03 March 2011; of record), as evidenced by Paradkar et al. (WO 2011/092511 A1; published 04 August 2011; of record).
Hardy et al. discloses a haemostatic material comprising a carrier layer and a material for wound contact comprising at least one haemostat in particulate, granular, powder, flake or short fibrous form, wherein such a haemostatic material is useful, for example, in reducing or stopping bleeding of a physiological target site in a person or animal, and can also be used to stem bleeding during medical procedures (abstract; claim 1). An embodiment discloses the haemostat mixed with adhesive layer to form a combined layer (i.e., a haemostatic material) on a carrier layer (paragraphs [0019], [0025], [0088], [0098]; Figure 2; claim 11). The haemostatic material typically comprises chitosan succinate (i.e., cationic) (paragraph [0036]; claim 16). The haemostat comprises short fibres no more than about 7.5mm in length (claim 19), and more typically no more than about 5 mm in length (paragraph [0039]). The haemostat has a pH of from about 3.5 to about 8.0 (claim 34). Addition to the haemostat of a combination of at least one inert material and a medical surfactant is particularly advantageous, wherein the inert material typically is granular (paragraphs [0053], [0054]; claim 24). Exemplary inert materials include acrylate (co)polymers such as Carbopol® (i.e., carbomer) and starch (paragraph [0056]; claim 25), which are bioadhesive agents/polymers, as evidenced by Paradkar et al. at page 12 paragraphs 2-3. Inert material constitutes up to about 95% by weight of the haemostat (claim 26). The medical surfactant comprises one or more components selected from the group consisting of block copolymers based on ethylene oxide and propylene oxide, fatty acids, fatty acid salts, silicone based surfactants and emulsifiers (claim 22), or a fatty acid selected from lauric acid and oleic acid (claim 23). The medical surfactant constitutes from about 0.001 to about 10% by weight of the haemostat (claim 21). The haemostat comprises particles which cannot pass through a 200 mesh sieve (claim 27). The carrier layer is in the form of a viscose non-woven material, woven gauze, film, foam, or sheet gel (claims 30, 31). The carrier layer is made of oxidised cellulose, collagen, polycaprylactone, polylactide acid, polylactide-co-glycolide, or polyglycolide (paragraph [0044]).
Since Hardy et al. discloses that addition to the haemostat of a combination of at least one inert material and a medical surfactant is particularly advantageous, wherein the inert material typically is granular (paragraphs [0053], [0054]; claim 24), that exemplary inert materials include acrylate (co)polymers such as Carbopol® (i.e., carbomer homopolymer or copolymer, anionic, comprises acrylic acid polymer cross-linked with allyl sucrose or allyl pentaerythritol) and starch (paragraph [0056]; claim 25), which are bioadhesive agents/polymers, as evidenced by Paradkar et al. at page 12 paragraphs 2-3, and that the inert material constitutes up to about 95% by weight of the haemostat (claim 26), it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Hardy et al. as discussed above and to make the haemostatic material of Hardy et al. as discussed above with up to about 95% by weight of granular carbomer, with a reasonable expectation of success. Such concentration range overlaps with the claimed concentration ranges of bioadhesive agent of 2-20% by weight or 5-10% or 7-8%, a prima facie case of obviousness exists per MPEP 2144.05(I).
Regarding the claimed recitation of the bioadhesive agent being present in an amount sufficient to provide adhesion to wet tissue while maintaining haemostatic performance, thereby enabling control of bleeding within a reduced compression time, such property is presumed inherent in the haemostatic material of Hardy et al. as discussed above per MPEP 2112(V) and 2112.01(I) given that such material and the claimed material are at least substantially identical as discussed above and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Regarding claims 6-7 and 9, Hardy et al. discloses that the haemostat typically constitutes at least about 20% by weight of the haemostat layer (paragraph [0038]). Since such concentration range overlaps with the claimed concentration ranges, a prima facie case of obviousness exists per MPEP 2144.05(I).
Regarding claims 14-17, since the claimed material and the haemostatic material of Hardy et al. as discussed above appear to be substantially identical, they are presumed to have the same properties per MPEP 2112(V), given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Regarding claims 25-27, Hardy et al. discloses that haemostat comprises more typically at least about 20% by weight of the haemostat material (paragraph [0038]), and that inert material, which includes bioadhesive agents/polymers as discussed above, comprises more typically up to about 80% by weight of the haemostat material (paragraph [0057]). Such amounts overlap with the claimed ratio ranges, and thus a prima facie case of obviousness exists per MPEP 2144.05(I). Moreover, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical, per MPEP 2144.05(11)(A). See In re AIler, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“Normally, it is to be expected that a change in temperature, or in concentration, or in both, would be an unpatentable modification.”); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843, 1844-48 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989) (claimed concentrations and weight ratios were obvious where prior art taught the combination but not the concentrations given that appropriate dosage testing is routine).
Regarding claim 28, Hardy et al. discloses that the haemostatic material typically comprises chitosan succinate (i.e., cationic) (paragraph [0036]; claim 16), and that exemplary inert materials include carbomer and/or alginate (i.e., anionic) (paragraph [0056]; claim 25) which is a bioadhesive agent, as evidenced by Paradkar et al. at page 12 paragraphs 2-3. It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to follow the suggestion of Hardy et al. and to include carbomer and alginate as inert material (bioadhesive) in the haemostat material as discussed above, with a reasonable expectation of success.
Regarding claims 29-32, it would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to follow the suggestions of Hardy et al. as discussed above and to include up to about 95% by weight granular starch as an inert material (bioadhesive) in the haemostat material as discussed above, with a reasonable expectation of success.
Regarding claim 38, Hardy et al. discloses that it is advantageous that the particle size of the surfactant is substantially equivalent to that of the haemostat, through grinding and sorting (paragraph [0052]). It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to make all particles sizes in the haemostat layer/material substantially equivalent, with a reasonable expectation of success, given that Hardy et al. suggests that substantially equivalent particle sizes are advantageous, and for convenience in simply grinding and sorting all particles in the haemostat material/layer at once.
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive.
Applicant argues that the amount of bioadhesive/inert material is not disclosed as a result-effective variable which rebuts the prima facie case of obviousness (remarks pages 7-8). In response, such reasoning applies to optimization as a rationale per MPEP 2144.05(III)(C), whereas the rejection is based on overlapping ranges rationale. Moreover, as discussed in MPEP 2144.05(III)(C), after KSR the presence of a known result-effective variable is no longer the only motivation to experiment that can be used in a prima facie obviousness determination.
Applicant argues that the claimed range of 2-20 wt% is critical and produces unexpected results (remarks pages 8-11). In response, such allegations of criticality/unexpected results were discussed in the previous Office action. In summary, declarant and applicant fail to show that the claims are commensurate in scope with the asserted unexpected results, and declarant and applicant fail to show that the results are unexpected. Declarant and applicant are encouraged to clearly list all ingredients and concentrations thereof for all tested compositions, along with test results for each tested composition. Declarant and applicant are also encouraged to concisely state how the results are unexpected as compared to the closest (or closer) prior art such as Hardy et al.
Applicant/declarant fails to specify all the constituents and concentrations thereof of the tested compositions such that it can be determined whether the asserted unexpected results are commensurate in scope with the claimed compositions; the asserted unexpected results are not commensurate in scope with the claimed compositions in that the claims include any haemostat agent chitosan salt but only 2 such salts are tested wherein such 2 salts produced very different results, and concentrations/amounts of haemostatic agents are not clearly evident; the asserted unexpected results are not commensurate in scope with the claimed compositions in that the claims include bioadhesive agents which were not tested (only CARBOPOL 980NF was tested, and the exact chemical nature/content of such CARBOPOL 980NF is not identified such that commensurateness can be determined); the asserted unexpected results are not commensurate in scope with the claimed compositions in that the claimed compositions include 2-20 wt% bioadhesive agent whereas testing only went down to 2.5 wt%, and testing for example at 30 wt% shows greater adhesion force for chitosan lactate than for example at 20 wt% for gelatin and thus it is for example not clear that 20 wt% is a critical upper limit with respect to adhesion force for all claimed haemostatic agents.
The burden is on applicant to establish that results are in fact unexpected and unobvious and of both statistical and practical significance, per MPEP 716.02(b). Such evidence of unexpected results must be commensurate in scope with the claimed invention per MPEP 716.02(d).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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, Sue Liu can be reached on (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
Prosecution Insights