DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim Status
Applicant’s amendment of 06/08/2026 is acknowledged. Claims 1, 7, 12, and 21-24 are amended, and claims 2, 4-6, 8, 10-11, 13, and 15-20 are cancelled. 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/01/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Previous Rejections/Objections
Applicant’s arguments filed 06/08/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied as necessitated by Applicant’s amendment to the claims. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Applicant’s arguments insofar as they pertain to the present grounds of rejections and/or objections are addressed herein.
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 12 and 14 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 12 recites the limitation “forming a dry, flowable hemostatic material by reconstituting cross-linked gelatin with feracrylum to form a gelatin matrix”. Absent a limiting definition of the term “reconstituting” provided in Applicant’s instant disclosure, the term is interpreted according to its customary meaning given by those of ordinary skill in the art, which is “to restore to a former condition by adding liquid”, as evidenced by Merriam-Webster [pg. 3, “Medical definition of reconstitute”; archived: 11/14/2019; PTO-892 of instant action]. This definition is consistent with Applicant’s instant specification, which states that “disclosed embodiments can comprise reconstituting the substrate, for example the cross-linked gelatin granules, with a solution containing a hemostatic agent, for example feracrylum” [instant spec., 061]. Considering this definition, it is unclear how the claimed reconstitution step is carried out such that it would produce a dry material. The claim simply recites “feracrylum” which, unless specified as being in solution, is a dry powder and thus would not be capable of “reconstituting” cross-linked gelatin as understood in the art. Is the feracrylum required to be in solution form, and is the cross-linked gelatin in a dried form? If so, how is the resulting material dry? Is there an unclaimed lyophilization step required to dry the reconstituted material? The claim could also be interpreted to mean that the cross-linked gelatin is reconstituted together with the feracrylum, as in both components are each subject to reconstitution by a solvent or solution. Because one of ordinary skill in the art could not readily ascertain the metes and bounds of the claimed method, the claim is indefinite. Claim 14 is rejected by virtue of its dependency on claim 12, as it fails to resolve the ambiguity in question. For examination purposes and because claim 12 requires that a dry hemostatic material is formed and applied to the treatment site, the Examiner is interpreting the claim to mean that mixing dry cross-linked gelatin with dry feracrylum to form a dry, flowable hemostatic material is sufficient to read on the instantly claimed reconstitution step.
Claim 12 recites the limitation “forming a…hemostatic material by reconstituting cross-linked gelatin with feracrylum to form a gelatin matrix” [lines 3-4], which suggests that the hemostatic material formed is a gelatin matrix of cross-linked gelatin and feracrylum. However, the claim also recites that the hemostatic material comprises the gelatin matrix and a hemostatic agent comprising -the feracrylum [lines 5-6]. It is unclear whether the gelatin matrix, which appears to include the feracrylum, and the hemostatic agent comprising the feracrylum are separate components of the hemostatic material. Therefore, one of ordinary skill in the art could not readily ascertain the scope of the claimed invention. Claim 14 is rejected by virtue of its dependency on claim 12, as it fails to resolve the ambiguity in question. For examination purposes and because Applicant’s instant disclosure provides no limiting definition of gelatin “matrix”, the Examiner is interpreting the claim to mean that the reconstitution step, which is interpreted as mixing cross-linked gelatin and feracrylum (see above), necessarily results in the formation of a gelatin matrix comprising the feracrylum.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12 and 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New Matter Rejection
The limitation “forming a dry, flowable hemostatic material by reconstituting cross-linked gelatin with feracrylum to form a gelatin matrix” has been added to claim 12 in the amendment filed on 06/08/2026. The instant disclosure does not provide support for reconstituting these two components to form a dry material as recited in the amended claims. In particular, the instant specification and claims as originally filed only provide support for reconstituting the cross-linked gelatin granules with a solution containing feracrylum, followed by application to a treatment site [061]. While Applicant does have support for adding dry feracrylum to cross-linked gelatin granules to form a hemostatic material [064-071], this embodiment does not involve “reconstituting” the cross-linked gelatin in view of the customary meaning of the term given by those of ordinary skill in the art, which is discussed above in relation to rejections under 35 U.S.C. 112(b). Further, the instant disclosure does not provide support for the combination of cross-linked gelatin and feracrylum forming a gelatin matrix. In particular, the instant specification only provides support for a hemostatic material comprising a cross-linked protein matrix and a synthetic biopolymer, e.g., feracrylum, as separate components [006-007]. In fact, Applicant’s FIG. 2 discloses that the cross-linked gelatin matrix is what is reconstituted with feracrylum, not that the combination of cross-linked gelatin and feracrylum form the gelatin matrix as recited in the amended claims [015].
If Applicant believes this rejection is in error, Applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, claim 12 represents new matter. Claim 14 is rejected by virtue of its dependency on claim 12.
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) Chauhan et al. 2017 (PTO-892 of 09/06/2024), and Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action) 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 [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 [0052; 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 spec., 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 [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; 0014]. In certain embodiments, the dry composition can be directly applied to the target site [0046], which reads on the instantly claimed method step.
Regarding claims 21-24: Goessl teaches that the dry preparation of a biocompatible polymer may be formed from combinations of biologic and non-biologic polymers [0037]. Biologic polymers include gelatin, collagen, albumin, casein, fibrinogen, fibrin, fibronectin, elastin, keratin, and laminin, or derivatives and combinations thereof [0037; claim 12]. Other suitable biologic polymers include polysaccharides, such as glycosaminoglycans, starch derivatives, cellulose derivatives, hemicellulose derivatives, xylan, agarose, alginate, and chitosan, or derivatives or combinations thereof [0037; claim 13]. Nonbiologic hydrogel-forming polymers include synthetics, such as polyacrylates, polymethacrylates, polyacrylamides, polyvinyl resins, polylactide-glycolides, polycaprolactones, and polyoxyethylenes, or derivatives or combinations thereof [0037; claim 14]. Thus, it would have been prima facie obvious to further include one or several of these biologic and non-biologic polymers in the cross-linked gelatin since the reference expressly suggests their combination, and the combination would yield nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
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, that feracrylum is present in an amount of at least 5 wt.% and less than 100 wt.% of the hemostatic composition, or that the cross-linked gelatin is cross-linked by genipin as required by instant claims 1, 7, and 12. Further, Goessl does not expressly teach that the hemostatic composition is formed by reconstituting cross-linked gelatin with feracrylum to form a gelatin matrix as recited in claim 12.
Belozerskaja teaches a hemostatic powder containing sodium alginate and feracryl in a weight ratio of 1:1-3 [abstract; claims]. The hemostatic powder stops bleeding and forms a film upon contact with blood and tissue in approximately 10-30 seconds [0004]. Feracryl is also known as feracrylum, as evidenced by Singh [pg. 157, first para. 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 [pg. 320]. Feracrylum is biocompatible and biodegradable, having no local or systemic adverse effects thus rendering it safe and economical [pg. 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 [pg. 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 [pg. 322].
Sanders teaches that flowable hemostatic compositions using various polymers and in particular genipin-crosslinked biological material, such as genipin-crosslinked gelatin, are well-established in the literature and are routinely used in the field of surgery and wound care [0047].
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.
Regarding the cross-linked gelatin recited in claims 1, 7, and 12: While the exemplary methods of Goessl use cross-linking agents such as glutaraldehyde to produce cross-linked gelatin [0043], it would have been prima facie obvious to substitute glutaraldehyde with genipin because Sanders teaches that this is a known gelatin cross-linking agent particularly suitable for forming flowable hemostatic materials and recognizes both glutaraldehyde and genipin as suitable for this purpose [Sanders, 0009]. Because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the method step “forming a dry, flowable…to form a gelatin matrix” recited in claim 12: Goessl teaches an embodiment wherein the dry preparation of coagulation inducing agent and dry preparation of biocompatible polymer are mixed in the container [claims 1 and 7]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to mix the cross-linked gelatin matrix with the feracrylum according to known methods to yield the predictable result of a dry, flowable hemostatic material. As discussed above in relation to rejections under 112(b), mixing dry cross-linked gelatin with dry feracrylum meets the instant limitation “forming a dry, flowable…to form a gelatin matrix”.
Since the hemostatic composition taught by Goessl in view of Belozerskaja, Chauhan, and Sanders 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 is a suitable hemostatic agent and Sanders teaches that genipin is a suitable gelatin cross-linking 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 06/08/2026 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.
Applicants argue that Goessl does not teach or suggest the use of genipin as a cross-linking agent or reconstituting cross-linked gelatin with feracrylum, and that none of Belozerskaja, Chauhan, or Singh cure the deficiencies of Goessl. These arguments were not found to be persuasive in view of Sanders for the reasons discussed in detail in the prior art rejections above.
In response to Applicant’s assertion that Goessl’s disclosed cross-linking agents do not include genipin, which appears to be in reference to Goessl’s paragraph 0038, the Examiner notes that Goessl specifically discloses these as suitable agents for crosslinking the biocompatible polymer (e.g., gelatin) with a rehydration aid, not for crosslinking the biocompatible polymer itself. Even so, the reference also states that “[a]lternatively, cross-linking may be achieved by using oxidizers and other agents” to activate polymer side-chains or moieties so that they may react to form the cross-linking bonds. Therefore, the reference does not limit the cross-linking agent to the aforementioned examples. As discussed in further detail above, because Sanders establishes that genipin is a known gelatin cross-linking agent useful for producing flowable hemostatic materials, the cross-linked gelatin as instantly claimed is rendered prima facie obvious.
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), Chauhan et al. 2017 (PTO-892 of 09/06/2024), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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 ‘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, or that the cross-linked gelatin is cross-linked by genipin as recited in instant claims 1, 7, and 12, or the reconstitution step recited in instant claim 12.
These deficiencies are cured by the teachings of Belozerskaja, Chauhan, Sanders, and Goessl 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.
Regarding the cross-linked gelatin recited in claims 1, 7, and 12: It would have been prima facie obvious to use genipin to cross-link the gelatin because Sanders teaches that this is a known gelatin cross-linking agent particularly suitable for forming flowable hemostatic materials. Because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Regarding the method step “forming a dry, flowable…to form a gelatin matrix” recited in claim 12: Goessl teaches an embodiment wherein the dry preparation of coagulation inducing agent and dry preparation of biocompatible polymer are mixed in the container [claims 1 and 7]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to mix the cross-linked gelatin matrix with the feracrylum according to known methods to yield the predictable result of a dry, flowable hemostatic material. As discussed above in relation to rejections under 112(b), mixing dry cross-linked gelatin with dry feracrylum meets the instant limitation “forming a dry, flowable…to form a gelatin matrix”.
Since the hemostatic composition taught by the combination of US ‘348 claims in view of Belozerskaja, Chauhan, Sanders, and Goessl 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 is a suitable hemostatic agent and Sanders teaches that genipin is a suitable gelatin cross-linking 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), Chauhan et al. 2017 (PTO-892 of 09/06/2024), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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 ‘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, Chauhan, Sanders, and Goessl 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), Chauhan et al. 2017 (PTO-892 of 09/06/2024), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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 ‘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, Chauhan, Sanders, and Goessl 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), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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, Chauhan, Sanders, and Goessl 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 mixture taught by the combination of US ‘176 claims, Belozerskaja, Chauhan, Sanders, 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 mixture taught by the combination of US ‘176 claims, Belozerskaja, Chauhan, Sanders, 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 ‘176 claims, Belozerskaja, Chauhan, Sanders, and Goessl 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), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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, Chauhan, Sanders, and Goessl and as evidenced by Singh, which is discussed in detail above.
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 Chauhan, Sanders, and Goessl 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 [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, Sanders, 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, Sanders, 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, Chauhan, Sanders, and Goessl 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), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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, Chauhan, Sanders, and Goessl 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 taught by the combination of US ‘945 claims, Belozerskaja, Chauhan, Sanders, 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.
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), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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, Chauhan, Sanders, and Goessl and as evidenced by Singh, which is discussed in detail above.
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, Chauhan, Sanders, and Goessl 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, Chauhan, Sanders, 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 ‘025 claims, Belozerskaja, Chauhan, Sanders, 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 ‘025 claims, Belozerskaja, Chauhan, Sanders, and Goessl 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), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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, Chauhan, Sanders, and Goessl 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 composition taught by the combination of US ‘335 claims, Belozerskaja, Chauhan, Sanders, 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 ‘335 claims, Belozerskaja, Chauhan, Sanders, 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 ‘335 claims, Belozerskaja, Chauhan, Sanders, and Goessl 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), Chauhan et al. 2017 (PTO-892 of 09/06/2024), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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 ‘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, Chauhan, Sanders, and Goessl 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), Chauhan et al. 2017 (PTO-892 of 09/06/2024), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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 ‘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, Chauhan, Sanders, and Goessl 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), Chauhan et al. 2017 (PTO-892 of 09/06/2024), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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 ‘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, Chauhan, Sanders, and Goessl 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), Chauhan et al. 2017 (PTO-892 of 09/06/2024), Sanders (WO2016100861A1; published: 06/23/2016; PTO-892 of instant action), 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 ‘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, Chauhan, Sanders, and Goessl 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
Applicants’ arguments submitted on 06/08/2026 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.
Applicants’ 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.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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