DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 30 October 2025 has been entered.
Status
Applicant’s response dated 30 October 2025 to the previous Office action dated 30 April 2025 is acknowledged. Claims 1, 3-7, 9, 11-17, 21-22, and 24-48 are pending in the application.
The rejection under 35 U.S.C. 103 made in the previous Office action is maintained.
The double patenting rejections made in the previous Office action are maintained as set forth below.
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Claims 43-44 and 46-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 § 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 alginate (i.e., anionic), xanthan gum, chitosan, pectin, collagen, gelatin, polyvinylalcohol, and starch (paragraph [0056]; claim 25), all of 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 alginate (i.e., anionic), xanthan gum, chitosan, pectin, collagen, gelatin, polyvinylalcohol, and starch (paragraph [0056]; claim 25), all of 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 polyvinyl alcohol, 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 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 claim 24, Hardy et al. discloses that an exemplary inert material is acrylate polymer such as CARBOPOL (paragraph [0056]). 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 add up to about 95% by weight CARBOPOL (i.e., a carbomer homopolymer or copolymer) to the haemostat material as discussed above, with a reasonable expectation of success.
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 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 alginate 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3, 14-17, 21-22, 28-31, 39-40, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 of U.S. Patent No. 9,750,843.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘843 claims recite a chitosan salt haemostat (i.e., cationic) and various bioadhesive agents and inerts such as polyvinyl alcohol, collagen, alginate (i.e., anionic), and starch.
Claims 1, 3, 14-17, 28-31, 40, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,973,946.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘946 claims recite a chitosan salt haemostat (i.e., cationic) and various bioadhesive agents and inerts such as polyvinyl alcohol, collagen, and starch.
Response to Declaration and Arguments
The declaration under 37 CFR 1.132 filed 30 October 2025, and arguments filed therewith, have been fully considered but they are insufficient to overcome the obviousness rejection and double patenting rejections as set forth in the last Office action for the same reasons provided 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.
For convenience, the full discussion of the previous declaration and arguments from the previous Office action is copied below.
Applicant argues that claim 1 has been amended to recite a reduced list of haemostat agents selected from gelatin, zeolite, and chitosan salt, such that the claims are now commensurate in scope with the unexpected results presented in the declaration filed 10 September 2024, and that CARBOPOL 980NF is a carbomer, and that carbomers and the other claimed bioadhesive agents comprise either an alcohol or amide group and thus they possess similar chemical characteristics that impart hydrophilicity and water solubility such that the unexpected results readily apply to such bioadhesive agents (remarks pages 9-12). In response, the declaration under 37 CFR 1.132 filed 10 September 2024 remains insufficient to overcome the obviousness and double patenting rejections herein because: it fails to specify all the constituents and concentrations thereof of the 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; 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%; the asserted unexpected results are not commensurate in scope with the claimed compositions and/or (at least some of) the results are not unexpected in that the testing shows results that appear not to be significantly different from standard adhesion of approximately 0.02N/cm (noted in last sentence of section 1 of report of Appendix A) (e.g., chitosan with 12.5% bioadhesive results in 0.022, chitosan with 20% bioadhesive results in 0.025, gelatin with 20% bioadhesive results in 0.028, collagen with 12.5% bioadhesive results in 0.021, collagen with 20% bioadhesive results in 0.020); and declarant’s opinions that Hardy et al.’s disclosure of up to 95 wt% inert material is “significantly far away from the amount provided by amended claim 1, and contradicts the teaching of claimed invention” and does not “directly and unambiguously” disclose 2-20% by weight of bioadhesive material as claimed, are not persuasive opinions because the prior art and claimed ranges overlap, and thus are not contradictory, and where prior art and claimed ranges overlap a prima facie case of obviousness exists per MPEP 2144.05(I). Moreover, applicant’s assertion that CARBOPOL 980NF is a carbomer, and that carbomers and the other claimed bioadhesive agents comprise either an alcohol or amide group and thus they possess similar chemical characteristics that impart hydrophilicity and water solubility such that the unexpected results readily apply to such bioadhesive agents, is not persuasive since the claimed bioadhesive agents encompass a wide variety of specific compounds and merely testing one of such compounds provides no indication that the asserted unexpected results can be reasonably extended to all such bioadhesive agents, and applicant does not provide the exact chemical nature/content of such CARBOPOL 980NF. Applicant is reminded that 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).
Applicant argues that the declaration provides evidence that the percentage bioadhesive agent is critical to the resulting adhesive force (remarks pages 12-13). In response, the declaration is not persuasive for the reasons provided above.
Applicant’s assertions that the double patenting rejections are moot (remarks pages 13-14) are not persuasive in that the declaration is not persuasive as discussed above.
Conclusion
No claims are allowed.
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.
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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.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617