DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Claim Status
Applicant’s amendment of 02/06/2026 is acknowledged. Claims 1, 7, and 12 are amended; claims 2, 4-6, 8, 10-11, 13, and 15-20 are cancelled; and claims 21-24 are new. Claims 1, 3, 7, 9, 12, 14, and 21-24 are currently pending and are examined on the merits herein.
Priority
The instant application claims domestic benefit to U.S. Application No. 63/275,209 filed on 11/03/2021 as reflected in the filing receipt dated on 01/19/2023.
Withdrawn Objections and Rejections
The previous rejections under 35 U.S.C. 103 and on the grounds of nonstatutory double patenting are hereby withdrawn in favor of the new/revised grounds of rejection presented below. Applicant’s arguments insofar as they pertain to the new/revised grounds of rejection are addressed herein.
Claim Objections
Claim 22 is objected to because of the following informalities:
Claim 22 recites the term “chitosan” in both lines 8 and 9, which is redundant. The term should only appear once in the claim.
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, 3, 7, 9, 12, 14, and 21-24 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.
Claims 1, 7, and 12 each recite the limitation wherein the biodegradable polymer comprises feracrylum in an amount that is “at least 5 wt.% of the hemostatic material”. It is unclear how the hemostatic material can comprise feracrylum in a range of at least 5 wt.%, which encompasses embodiments wherein feracrylum is present in an amount of 100 wt.%, and also comprise a gelatin matrix. Therefore, the scope of each claim is indefinite.
Claims 3 and 21-24 are rejected by virtue of their dependency on claim 1, and claims 9 and 14 are rejected by virtue of their dependency on claims 7 and 12, respectively, as they fail to resolve the ambiguity in question.
Claims 21 and 23 each recite the limitation “wherein the cross-linked gelatin comprises a protein…” It is not clear if “a protein” is the same protein inherently contained within the cross-linked gelatin or if it is an additional protein. If Applicant is intending to claim additional proteins, then the Examiner recommends amending the claim to read “wherein the cross-linked gelatin further comprises…”.
Claim 22 recites several polysaccharide species along with explicitly named derivatives thereof. For example, the claim recites: cellulose, along its derivatives alkyl cellulose, methylcellulose, etc.; hyaluronic acid, along with its derivatives salts of hyaluronic acid; alginate, along with its derivative alginic acid; dextran, along with its derivatives dextran sulfate and carboxymethyl dextran; chondroitin, along with its derivatives chondroitin sulfates; chitosan, along with its derivative carboxymethyl chitosan; heparan, along with its derivatives heparin, heparin sulfate, and heparan sulfate; starch, along with its derivatives amylose and amylopectin. Because the claim explicitly recites certain polysaccharide derivatives but also recites the broader limitation “derivatives of said polysaccharides”, it makes it unclear whether the derivatives that are explicitly recited in the claim are (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) required features of the claims. See MPEP § 2173.05(c). Because the claim does not clearly set forth the metes and bounds of the patent protection desired, the claim is indefinite.
Claim 23 recites the limitation “wherein the cross-linked gelatin comprises a protein selected from…gelatin…” It is not clear if “gelatin” is the same protein inherently contained within the cross-linked gelatin or if it is an additional, different type of gelatin. Therefore, the scope of the claim is indefinite. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting the claim to mean that it is the same gelatin inherently contained within the cross-linked gelatin.
Claim 24 recites the limitation “wherein the hemostatic material comprises a polymer…” It is not clear if “a polymer” is the same “biodegradable polymer” recited in claim 1 or if it is an additional polymer. If Applicant is intending to claim additional polymers, then the Examiner recommends amending the claim to read “wherein the hemostatic material further comprises…”.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Goessl (US20150367022A1; PTO-892 of 09/06/2024) in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
Goessl teaches a process for making a dry and stable hemostatic composition, the process comprising: preparing a dry preparation of a coagulation inducing agent in a container, and adding a dry preparation of a biocompatible polymer suitable for use in hemostasis to the container (Claim 2). The coagulation-inducing agent comprises a substance selected from thrombin, a snake venom, a platelet activator, a thrombin receptor activating peptide, and a fibrinogen precipitating agent (Claim 3) and is used in lyophilized form, preferably milled to obtain a powder form (Paragraph 0024). The biocompatible polymer is a cross-linked gelatin (Claim 17) and is used in the form of Floseal gelatin matrix, which comprises gelatin granules (Paragraphs 0052 and 0063).
Regarding the hemostatic material of claims 1, 3, 7, 9, 12, and 14: The dry and stable hemostatic composition taught by Goessl, which comprises a matrix of cross-linked gelatin granules and a powdered coagulation inducing agent, reads on the instantly claimed features “dry, flowable hemostatic material” comprising a “gelatin matrix” and a “hemostatic agent” as evidenced by the instant specification, which states the material can be “provided in flowable dry form (e.g. as granules or as a powder)” (Instant Specification, Paragraph 056). It also reads on the instantly claimed features wherein the gelatin matrix comprises “a cross-linked gelatin” and “gelatin granules”.
Regarding the kit of claim 7: Goessl further teaches a kit comprising the dry and stable hemostatic composition and a container with a stable diluent (Paragraph 0049), which reads on the components of the instantly claimed kit.
Regarding the method of claim 12: Goessl further teaches a method for delivering the hemostatic composition, which is particularly useful for providing hemostasis at bleeding sites, to a target site in a patient’s body (Claim 19 and Paragraph 0014). In certain embodiments, the dry composition can be directly applied to the target site (Paragraph 0046), which reads on the instantly claimed method step.
Regarding claims 21 and 23: The cross-linked gelatin of Goessl reads on the instantly claimed protein, as evidenced by instant claim 23, and thus meets the claims.
Regarding claim 22: Goessl teaches that combinations of different kinds of polymers are possible, e.g. proteins with polysaccharides, proteins with non-biologic hydrogel-forming polymers, etc. (Paragraph 0037), wherein suitable polysaccharides include glycosaminoglycans, starch derivatives, cellulose derivatives, hemicellulose derivatives, xylan, agarose, alginate, chitosan, or derivatives or combinations thereof (Paragraph 0037 and Claim 13). Therefore, an ordinarily skilled artisan could at once envisage an embodiment wherein the cross-linked gelatin further comprises a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, alginate derivatives, chitosan, or chitosan derivatives, which read on the polysaccharides and derivatives recited in the instant claim.
Regarding claim 24: Goessl teaches that exemplary nonbiologic hydrogel-forming polymers that may be combined with proteins (i.e. the cross-linked gelatin of Goessl) include synthetics, such as polyacrylates, polymethacrylates, polyacrylamides, polyvinyl resins, polylactide-glycolides, polycaprolactones, and polyoxyethylenes, or derivatives or combinations thereof (Paragraph 0037 and Claim 14). Therefore, an ordinarily skilled artisan could at once envisage an embodiment wherein the hemostatic composition further comprises a polymer selected from those taught by Goessl, which read on the polymers and derivatives recited in the instant claim.
While Goessl does teach non-thrombin coagulation inducing agents, Goessl does not expressly teach that the coagulation inducing (i.e. hemostatic) agent is synthetically-derived comprising a biodegradable polymer comprising feracrylum, or that feracrylum is present in an amount of at least 5 wt.% of the hemostatic composition as required by instant claims 1, 7, and 12.
Belozerskaja teaches a hemostatic powder containing sodium alginate and feracryl in a weight ratio of 1:1-3 (Abstract and Claims). The hemostatic powder stops bleeding and forms a film upon contact with blood and tissue in approximately 10-30 seconds (Paragraph 0004). Feracryl is also known as feracrylum, as evidenced by Singh (Page 157, First Paragraph and References).
Chauhan teaches the advantageous properties of the hemostatic agent feracrylum, which is a water-soluble mixture of incomplete ferrous of salt and polyacrylic acid (Page 320). Feracrylum is biocompatible and biodegradable, having no local or systemic adverse effects thus rendering it safe and economical (Page 320). It is also anti-infective against a number of pathogenic bacterial and fungal strains, thereby decreasing risk of wound infection, and is hygroscopic in nature, allowing for a moist environment at wound site and resulting in faster healing (Page 320 and 323). Its hemostatic action is derived from its ability to activate thrombin, which is a serine protease that converts soluble fibrinogen into insoluble strands of fibrin (i.e., initiates fibrinogen precipitation), thus forming a clot and catalyzing other coagulation-related reactions (Page 322).
Regarding the hemostatic agent of claims 1, 7, and 12: It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hemostatic composition of Goessl by substituting the coagulation inducing agent with the powder feracrylum taught by Belozerskaja and further supported by Chauhan according to known methods to yield the predictable result of a dry, flowable hemostatic composition. One of ordinary skill in the art would have been motivated to use feracrylum to impart additional beneficial properties to the hemostatic composition that are known to prevent infection and accelerate wound healing and because feracrylum is known in the art to be systemically safe and economical.
Regarding the amount of feracrylum recited in claims 1, 7, and 12: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the concentration of feracrylum using 50 wt.%, which lies within and thus renders obvious the instantly claimed range, as a starting point for routine optimization because Belozerskaja teaches that a 1:1 weight ratio of polymer to feracrylum is suitable to stop bleeding in 10 to 30 seconds.
Since the hemostatic composition taught by Goessl in view of Belozerskaja and Chauhan comprises feracrylum as the coagulation inducing agent, the composition as taught by the prior art meets the instantly claimed limitation “wherein said synthetically-derived hemostatic agent does not comprise thrombin” as recited in instant claims 1, 7, and 12.
One of ordinary skill in the art would have a reasonable expectation of success because Belozerskaja demonstrates that feracrylum a suitable hemostatic agent for use in dry hemostatic compositions. Goessl also recognizes the compatibility of polyacrylates, like feracrylum, in its invention. Importantly, Chauhan teaches that feracrylum activates biological thrombin, which would produce the same downstream blood coagulation events as the coagulation inducing agents taught by Goessl, including the conversion of soluble fibrinogen into insoluble fibrin strands (i.e., fibrinogen precipitation). Goessl teaches that any fibrinogen precipitating agent is a suitable coagulation inducing agent, further supporting the predictably of using feracrylum.
Response to Arguments
Applicant’s arguments submitted on 02/06/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that the cited references do not disclose wherein the biodegradable polymer comprises at least 5 wt.% feracrylum. This argument was not found to be persuasive in view of the prior art combination above, wherein Goessl in view of Belozerskaja and Chauhan teaches all features of the hemostatic agent comprising a biodegradable polymer as instantly claimed.
Applicant further argues that the instant disclosure is sufficient to show unexpected results superior to the use of feracrylum alone or thrombin as disclosed in the cited references. Applicant relies on FIG. 1-3 of the instant specification to show that a cross-linked gelatin matrix reconstituted with feracrylum (FIG. 2) “compares favorably” to the composition reconstituted with thrombin (FIG. 3) and even shows a “quicker clotting time”. The Examiner respectfully maintains the position that Applicant’s data is insufficient to demonstrate unexpectedly superior results for the reasons discussed in detail in the Advisory Action dated 01/27/2026 and reiterated briefly below.
First, the Examiner maintains that the comparative data are presented in different scales (e.g., FIG. 2 is represented on a 20 mm scale, and FIG. 3 is represented on a 10 mm scale) which cannot be directly compared. Applicant’s assertion that “[t]he steeper angle shows a quicker clotting time” is nonspecific and does not allow an ordinarily skilled artisan to directly compare the “steepness” of each data point.
Second, the Examiner maintains that Applicant has not established that the results are of statistical significance. It is unclear that the feracrylum-based matrix performs superiorly to the thrombin-based matrix because Applicant merely states that the clotting data "compare favorably" without providing data to support that the "quicker clotting time" achieved by the feracrylum-based matrix is significantly quicker than the clotting time achieved by the thrombin-based matrix.
The Examiner further notes that the instant composition is drawn to a dry hemostatic material. Thus, it is unclear how the presented data, wherein the cross-linked gelatin matrix is “reconstituted” with feracrylum is commensurate in scope with Applicant’s invention as defined in the claims.
Even if Applicant’s results were shown to be both commensurate in scope and statistically significant, in view of the prior art of record, it is unclear whether Applicant’s allegedly unexpected results are actually unexpected. For example, Belozerskaja teaches that feracrylum is known to stop bleeding within 10 to 30 seconds, which under broadest reasonable interpretation represents a quick clotting time. Additionally, Chauhan teaches that feracrylum causes activation of thrombin. Therefore, an ordinarily skilled artisan would reasonably expect a composition comprising feracrylum to have a comparable clotting time to a composition comprising thrombin.
In absence of established statistical significance and because it is not clear that the argued unexpected results are actually unexpected based on the teachings of Belozerskaja and Chauhan, the invention as a whole would have been 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 objective evidence to the contrary. In view of the foregoing, the prior art rejections of record are maintained.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘348 recite a dry and stable hemostatic composition comprising a dry preparation of thrombin and a dry preparation of biocompatible polymer, wherein the biocompatible polymer is a cross-linked gelatin in particulate form. Because the instant specification provides no limiting definition as to what constitutes a "granule", under broadest reasonable interpretation, the particulate cross-linked gelatin reads on the instantly claimed gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘348 also recite that the composition is in a container that also comprises a syringe, a vial, and/or a tube. The claims of US ‘348 also recite a method for delivering the composition to a target site in a patient’s body. Under broadest reasonable interpretation, the term “delivering” reads on the step of “applying” the composition to the treatment site. The claims of US ‘348 also recite that the biocompatible polymer may contain a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, chitosan, and derivatives or combinations thereof, and/or a polymer selected from polyacrylates, polymethacrylates, polyacrylamides, polyvinyl resins, polylactide-glycolides, polcaprolactones, polyoxyethlenes, and derivatives and combinations thereof.
The claims of US ‘348 differ from the instant claims in that they do not expressly recite that the composition comprises feracrylum in an amount of 5 wt.% of the hemostatic material, rather than thrombin, as recited in instant claims 1, 7, and 12.
These deficiencies are cured by the teachings of Belozerskaja and Chauhan as evidenced by Singh, which are as set forth above and further incorporated herein.
Regarding the hemostatic agent of instant claims 1, 7, and 12: It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hemostatic composition recited in the claims of US ‘348 by substituting the coagulation inducing agent with the powder feracrylum taught by Belozerskaja and further supported by Chauhan according to known methods to yield the predictable result of a dry, flowable hemostatic composition. One of ordinary skill in the art would have been motivated to use feracrylum to impart additional beneficial properties to the hemostatic composition that are known to prevent infection and accelerate wound healing and because feracrylum is known in the art to be systemically safe and economical.
Regarding the amount of feracrylum recited in instant claims 1, 7, and 12: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the concentration of feracrylum using 50 wt.%, which lies within and thus renders obvious the instantly claimed range, as a starting point for routine optimization because Belozerskaja teaches that a 1:1 weight ratio of polymer to feracrylum is suitable to stop bleeding in 10 to 30 seconds.
Since the hemostatic composition taught by the combination of US ‘348 claims in view of Belozerskaja and Chauhan comprises feracrylum rather than thrombin, the composition as taught by the prior art meets the instantly claimed limitation “wherein said synthetically-derived hemostatic agent does not comprise thrombin” as recited in instant claims 1, 7, and 12.
One of ordinary skill in the art would have a reasonable expectation of success because Belozerskaja demonstrates that feracrylum a suitable hemostatic agent for use in dry hemostatic compositions. The claims of US ‘348 also recite that polyacrylates, like feracrylum, are suitable for use in the composition. Importantly, Chauhan teaches that feracrylum activates biological thrombin, which would produce the same downstream blood coagulation events as the thrombin recited in the claims of US ‘348.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,084,728 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘728 recite a dry and stable hemostatic composition comprising a dry preparation of thrombin and a dry preparation of biocompatible polymer, wherein the biocompatible polymer is a cross-linked gelatin in particulate form. Because the instant specification provides no limiting definition as to what constitutes a "granule", under broadest reasonable interpretation, the particulate cross-linked gelatin reads on the instantly claimed gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘728 also recite that the components are combined in a syringe. The claims of US ‘728 also recite a method for delivering the composition to a target site in a patient’s body. Under broadest reasonable interpretation, the term “delivering” reads on the step of “applying” the composition to the treatment site. The claims of US ‘728 also recite that the biocompatible polymer may contain a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, chitosan, and derivatives or combinations thereof, and/or a polymer selected from polyacrylates, polymethacrylates, polyacrylamides, polyvinyl resins, polylactide-glycolides, polcaprolactones, polyoxyethlenes, and derivatives and combinations thereof.
The claims of US ‘728 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,994,045 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘045 recite a dry and stable hemostatic composition comprising a dry preparation of a coagulation inducing agent, which may be thrombin, and a dry preparation of biocompatible polymer, wherein the biocompatible polymer is a cross-linked gelatin in granular form. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘045 also recite that the components are combined in a final container that is a syringe. The claims of US ‘045 also recite that the biocompatible polymer may contain a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, chitosan, and derivatives or combinations thereof, and/or a polymer selected from polyacrylates, polymethacrylates, polyacrylamides, polyvinyl resins, polylactide-glycolides, polcaprolactones, polyoxyethlenes, and derivatives and combinations thereof.
The claims of US ‘045 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the hemostatic composition recited in the claims of US ‘045 to a treatment site to control bleeding because that is the ultimate purpose of any hemostatic composition.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,208,176 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action), Chauhan et al. 2017 (PTO-892 of 09/06/2024), and Goessl (US20150367022A1; PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘176 recite a sterile dry mixture comprising a dry preparation of thrombin and a dry preparation of cross-linked gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘176 also recite that the components are combined in a syringe.
The claims of US ‘176 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
The teachings of Goessl are as set forth above and further incorporated herein.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the mixture taught by the combination of US ‘176 claims, Belozerskaja, and Chauhan to a treatment site to control bleeding because Goessl teaches that dry compositions comprising a coagulation inducing agent and a cross-linked gelatin are particularly useful for that purpose.
Regarding instant claim 22: It would have been prima facie obvious to one of ordinary skill in the art to modify the mixture taught by the combination of US ‘176 claims, Belozerskaja, and Chauhan by further including a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, alginate derivatives, chitosan, or chitosan derivatives in order to optimize the hemostatic properties of the cross-linked gelatin because Goessl teaches that these are particularly useful in combination with proteins for formulating effective hemostatic compositions.
Regarding instant claim 24: The feracrylum taught by the combination of US ‘176 claims, Belozerskaja, and Chauhan is a polyacrylate polymer and thus meets the claim.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,343,385 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action), Chauhan et al. 2017 (PTO-892 of 09/06/2024), and Goessl (US20150367022A1; PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘385 recite a hemostatic material comprising a hemostatic agent, which may comprise thrombin, and a substrate material, wherein the substrate material is a cross-linked gelatin comprising gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. Although the claims recited that the hemostatic agent and substrate material are separated by a membrane, the claims are drawn to a system for administering a hemostatic material ultimately comprising both elements. The claims of US ‘385 also recite a kit wherein the components are combined in a syringe.
The claims of US ‘385 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
The teachings of Goessl are as set forth above and further incorporated herein.
Regarding the limitation “dry, flowable” recited in instant claims 1, 7, and 12: While the hemostatic material taught by the combination of US ‘385 claims, Belozerskaja, and Chauhan may, in fact, be in dry form it would have been prima facie obvious to one of ordinary skill in the art to formulate the material in dry granular form because Goessl teaches that this form is known to be storage-stable with less tendency to form clumps when flowing (Paragraphs 0003 and 0023).
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the hemostatic material taught by the combination of US ‘385 claims, Belozerskaja, Chauhan, and Goessl to a treatment site to control bleeding because Goessl teaches that dry compositions comprising a coagulation inducing agent and a cross-linked gelatin are particularly useful for that purpose.
Regarding instant claim 22: It would have been prima facie obvious to one of ordinary skill in the art to modify the cross-linked gelatin taught by the combination of US ‘385 claims, Belozerskaja, Chauhan, and Goessl by further including a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, alginate derivatives, chitosan, or chitosan derivatives in order to optimize the hemostatic properties of the cross-linked gelatin because Goessl teaches that these are particularly useful in combination with proteins for formulating effective hemostatic compositions.
Regarding instant claim 24: The feracrylum taught by the combination of US ‘385 claims, Belozerskaja, and Chauhan is a polyacrylate polymer and thus meets the claim.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-29, and 36-42 of U.S. Patent No. 9,408,945 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action), Chauhan et al. 2017 (PTO-892 of 09/06/2024), and Goessl (US20150367022A1; PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘945 recite a dry and stable hemostatic composition comprising thrombin and a biocompatible polymer, wherein the biocompatible polymer is a cross-linked gelatin in granular form. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘945 also recite that the components are combined in a syringe as a final container. The claims of US ‘945 also recite that the biocompatible polymer may contain a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, chitosan, and derivatives or combinations thereof, and/or a polymer selected from polyacrylates, polymethacrylates, polyacrylamides, polyvinyl resins, polylactide-glycolides, polcaprolactones, polyoxyethlenes, and derivatives and combinations thereof.
The claims of US ‘945 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
The teachings of Goessl are as set forth above and further incorporated herein.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the hemostatic composition taught by the combination of US ‘945 claims, Belozerskaja, and Chauhan to a treatment site to control bleeding because Goessl teaches that dry compositions comprising a coagulation inducing agent and a cross-linked gelatin are particularly useful for that purpose.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-22 and 28-34 of U.S. Patent No. 8,962,025 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action), Chauhan et al. 2017 (PTO-892 of 09/06/2024), and Goessl (US20150367022A1; PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘025 recite a mixed powder composition comprising a hydrogel forming component comprising cross-linked gelatin and an active agent, which may comprise thrombin. Because the instant specification provides no limiting definition as to what constitutes a "granule", under broadest reasonable interpretation, the cross-linked gelatin powder reads on the instantly claimed gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘025 also recite that the composition is disposed within a container of a kit.
The claims of US ‘025 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
The teachings of Goessl are as set forth above and further incorporated herein.
Regarding the kit of instant claim 7: It would have been prima facie obvious to one of ordinary skill in the art to modify the kit taught by the combination of US ‘025 claims, Belozerskaja, and Chauhan by further including a syringe because Goessl teaches that a syringe is useful for administering dry hemostatic compositions.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the mixed powder taught by the combination of US ‘025 claims, Belozerskaja, and Chauhan to a treatment site to control bleeding because Goessl teaches that dry compositions comprising a coagulation inducing agent and a cross-linked gelatin are particularly useful for that purpose.
Regarding instant claim 22: It would have been prima facie obvious to one of ordinary skill in the art to modify the cross-linked gelatin taught by the combination of US ‘025 claims, Belozerskaja, and Chauhan by further including a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, alginate derivatives, chitosan, or chitosan derivatives in order to optimize the hemostatic properties of the cross-linked gelatin because Goessl teaches that these are particularly useful in combination with proteins for formulating effective hemostatic compositions.
Regarding instant claim 24: The feracrylum taught by the combination of US ‘025 claims, Belozerskaja, and Chauhan is a polyacrylate polymer and thus meets the claim.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,940,335 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action), Chauhan et al. 2017 (PTO-892 of 09/06/2024), and Goessl (US20150367022A1; PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘335 recite a dry and stable hemostatic composition comprising a dry granular preparation of cross-linked gelatin coated with a coagulation inducing agent, which may be thrombin. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘335 also recite that the composition is in a final container that is a syringe.
The claims of US ‘335 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
The teachings of Goessl are as set forth above and further incorporated herein.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the composition taught by the combination of US ‘335 claims, Belozerskaja, and Chauhan to a treatment site to control bleeding because Goessl teaches that dry compositions comprising a coagulation inducing agent and a cross-linked gelatin are particularly useful for that purpose.
Regarding instant claim 22: It would have been prima facie obvious to one of ordinary skill in the art to modify the cross-linked gelatin taught by the combination of US ‘335 claims, Belozerskaja, and Chauhan by further including a polysaccharide selected from starch derivatives, cellulose derivatives, alginate, alginate derivatives, chitosan, or chitosan derivatives in order to optimize the hemostatic properties of the cross-linked gelatin because Goessl teaches that these are particularly useful in combination with proteins for formulating effective hemostatic compositions.
Regarding instant claim 24: Regarding instant claim 24: The feracrylum taught by the combination of US ‘335 claims, Belozerskaja, and Chauhan is a polyacrylate polymer and thus meets the claim.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,629,798 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘798 recite a dry powder hemostatic composition comprising cross-linked gelatin microspheres and thrombin. Because the instant specification provides no limiting definition as to what constitutes a "granule", under broadest reasonable interpretation, the cross-linked gelatin microspheres read on the instantly claimed gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘798 also recite a delivery device wherein the composition is in a syringe. The claims of US ‘798 also recite that the composition comprises poloxamer 188, which comprises polyoxyethylene as evidenced by its chemical structure, as a wetting agent and carboxymethylcellulose as a suspending agent.
The claims of US ‘798 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the hemostatic composition recited in the claims of US ‘798 to a treatment site to control bleeding because that is the ultimate purpose of any hemostatic composition.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 12-19 of U.S. Patent No. 10,124,068 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘068 recite a dry powder hemostatic composition comprising cross-linked gelatin microspheres and thrombin. Because the instant specification provides no limiting definition as to what constitutes a "granule", under broadest reasonable interpretation, the cross-linked gelatin microspheres read on the instantly claimed gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘068 also recite wherein the composition is in a syringe. The claims of US ‘068 also recite that the composition comprises poloxamer 188, which comprises polyoxyethylene as evidenced by its chemical structure, as a wetting agent and carboxymethylcellulose as a suspending agent.
The claims of US ‘068 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the hemostatic composition recited in the claims of US ‘068 to a treatment site to control bleeding because that is the ultimate purpose of any hemostatic composition.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 13 of U.S. Patent No. 10,232,046 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘046 recite a dry powder hemostatic composition comprising cross-linked gelatin microspheres and thrombin. Because the instant specification provides no limiting definition as to what constitutes a "granule", under broadest reasonable interpretation, the cross-linked gelatin microspheres read on the instantly claimed gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘046 also recite a kit wherein the composition is in a syringe. The claims of US ‘046 also recite that the composition comprises poloxamer 188, which comprises polyoxyethylene as evidenced by its chemical structure, as a wetting agent and carboxymethylcellulose as a suspending agent.
The claims of US ‘046 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the hemostatic composition recited in the claims of US ‘046 to a treatment site to control bleeding because that is the ultimate purpose of any hemostatic composition.
Claims 1, 3, 7, 9, 12, 14, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7-14 of U.S. Patent No. 11,246,938 B2 in view of Belozerskaja et al. (RU2304440C2; published: 08/20/2007; PTO-892 of instant action) and Chauhan et al. 2017 (PTO-892 of 09/06/2024) and as evidenced by Singh et al. (J. South Asian Feder. Obst. Gynae., vol. 7, p. 157; published: Dec. 2015; PTO-892 of instant action).
The claims of US ‘938 recite a dry powder hemostatic composition comprising cross-linked gelatin microspheres and thrombin. Because the instant specification provides no limiting definition as to what constitutes a "granule", under broadest reasonable interpretation, the cross-linked gelatin microspheres read on the instantly claimed gelatin granules. With no distinguishing structural features recited in the instant claims, the cross-linked gelatin also reads on the instantly claimed gelatin matrix. The claims of US ‘938 also recite that the composition is in a syringe. The claims of US ‘046 also recite that the composition comprises poloxamer 188, which comprises polyoxyethylene as evidenced by its chemical structure, as a wetting agent and carboxymethylcellulose as a suspending agent.
The claims of US ‘938 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-22 of U.S. Patent No. 10,245,348 B2 in view of Belozerskaja and Chauhan and as evidenced by Singh, which is discussed in detail above.
Regarding the method of instant claim 12: It would have been prima facie obvious to one of ordinary skill in the art to apply the hemostatic composition recited in the claims of US ‘938 to a treatment site to control bleeding because that is the ultimate purpose of any hemostatic composition.
Response to Arguments
Applicant’s arguments submitted on 02/06/2026 with respect to rejections under nonstatutory double patenting have been fully considered in so far as they apply to the new/modified rejections of the instant Office action. Applicant argues that this stage in prosecution is premature for terminal disclaimer and at such a time when the present claims are otherwise allowable, the Applicant will reconsider any remaining double patenting rejections. As there is no allowable subject matter indicated, the double patenting rejections of record are maintained.
Applicant's request for the double patenting rejections of record to be held in abeyance is acknowledged. However, this request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejections will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejections.
Conclusion
No claim is allowed.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616