DETAILED ACTION
Claims 1-21 are currently pending. Claims 1-4, 6, 8-9, 11-17 and 19-21 are currently under examination.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 01/20/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Examiner’s Note
Applicant's amendments and arguments filed 01/20/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 01/20/2026, it is noted that claim 1 is amended and no new matter or claims have been added.
New Rejections:
The following rejections are based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 contains the limitation of wherein the binder comprises high-G alginate. The instant specification defines high G alginate to be (e.g. a guluronate to mannonate ratio of greater than or equal to about 50%) [009]. Instant claim 1 has been amended to the binder comprising an alginate comprising a guluronic acid (G) content of at least about 50% by weight. Thus claim 4 does not further limit amended claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4, 6, 8-9, 11-17 and 19-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2007/0276345 (Applicant provided) in view of US 5,482,932 (Applicant provided).
Regarding claims 1, 9 and 19, the limitation of a hemostatic device comprising a substrate; a hemostatic material disposed on at least one side of the substrate and water-insoluble, crosslinked, biocompatible, polymer binder configured to immobile the hemostatic material on the substrate such that the hemostatic material does not visible separate from the substrate in the presence of water; wherein the hemostatic device is not saturated in its final state before use, wherein the binder as an effect of substantially retaining the hemostatic material on the substrate when exposed to blood is met by the ‘345 publication teaching a hemostatic device for promoting the clotting of blood including a gauze substrate, a clay material and polyol such as glycerol or the like disposed on the gauze substrate to bind the lay material. The wound is taught to have clotting as the bandage is applied (abstract, [0015]). The clay is taught to be aluminum silicate ([0035], [0037], [0064]). The material forming the strands incudes such a cotton, wool, silk or the like [0047]. The gauze may be crosslinked with a polysaccharide [0065], reading on does not visibly separate from the substrate in the presence of water. Binders are taught to include calcium alginate [0073]. The gauze substrate is taught as dried [0057].
Regarding claims 2 and 20, the limitation of wherein the substrate comprises a non-woven fabric is taught by the ‘345 publication teaching non-woven fibrous materials [0050].
Regarding claim 3, the limitation of wherein the substrate is rayon, polyester or a combination of the forgoing is met by the ‘345 publication teaching rayon and polyester [0050].
Regarding claim 6, the limitation of wherein the binder includes ionic crosslinks is met by the ‘345 publication teaching calcium alginate [0073] wherein the substrate is rayon or polyester [0050]. The instant specification evidences ionic bonds with calcium alginate [0070].
Regarding claims 8 and 12, the limitation of wherein the hemostatic device is flexible to allow the hemostatic device to form to shape of the bleeding wound and retain a shape of the bleeding wound is met by the ‘345 publication teaching a flexible substrate to be applied to a bleeding wound (abstract, [0052]).
Regarding claim 11, the limitation of wherein the immobilized hemostatic material is entrapped within a matrix of the binder is met by the ‘345 publication teaching using a binder by trapping the hemostatic material within the matrix and applied to the substrate [0072].
Regarding claim 13, the limitation of wherein the binder comprises a salt and is distinct form the binder is met by the ‘345 publication teaching calcium alginate [0073] wherein the substrate is rayon or polyester [0050].
Regarding claim 15, the limitation of wherein the substrate comprises strands is met by the substrate being taught to include strands [0047].
Regarding claim 16, the limitation of wherein the substrate is gauze is met by the ‘345 publication is gauze [0047].
The ‘345 publication does not specifically teach wherein the binder comprises alginate comprising a guluronic acid (G) content of at least about 50% by weight (claim 1) and a high-G alginate (claim 4).
The ‘932 patent teaches alginate gels prepared by treating a water-insoluble or water-swellable alginate fibers, for example calcium alginate fibers with an aqueous solution of solubilizing salt such as sodium chloride. The new gels are easier to handle than other known alginate gels and are useful in wound dressing (abstract). Alginate may be high G or high M alginate. High-G alginate gel is taught (column 3, lines 15-26). Water insoluble alginate is taught (column 3, lines 50-60). The alginate gel can be provided dry and has higher water absorbency (column 4, lines 63-65). Alginate gels may contain a conventional preservative for medical alginates. Such materials may be dissolved or suspended so they become incorporated into the gel during its manufacture (column 5, lines 10-25). The gels are moldable and highly conformable and may be used as dressings on curved surfaces and may be used to pack wounds (column 5, lines 35-45).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use high G alginate as taught by the ‘932 patent for the alginate taught by the ‘345 publication because the ‘932 patent and the ‘345 publication are both directed to wound dressing comprising alginate. One of ordinary skill in the art would be motivated to use the alginate gels of the ‘932 patent on the gauze of the ‘345 publication because the ‘932 patent teaches the alginate gels are moldable, highly conformable to be used in wound and have higher water absorbency. One of ordinary skill in the art would have a reasonable expectation of success as the ‘345 patent teaches crosslinking a calcium alginate to the gauze wherein the alginate contains an active agent and the ‘932 patent teaches calcium alginate gels which contain an active agent.
Claims 17 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2007/0276345 and US 5,482,932 as applied to claims 1-4, 6, 8-9, 11-17 and 19-21 above, and further in view of US 4,390,519 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-4, 6, 8-9, 11-17 and 19-21 are taught by the combination of the ‘345 publication and the ‘932 patent.
The combination of references does not specifically teach the hemostatic device is provided in a sterilized packaging (claim 17).
The combination of references does not specifically teach a bandage with a pressure-sensitive adhesive on a skin-contacting surface of the bandage configured to adhere the bandage to the skin of a wearer (claim 21).
The ‘519 patent teaches improved hemostatic article with a pad or sponge employed to control or terminate bleeding (abstract). Modified hemostatic agent is incorporated in a porous body to produce a superior hemostatic bandage. The supporting on is a small gauze pad mounted on an adhesive step (column 4, lines 55-68). The whole bandage is taught as packed and sterilized using gamma radiation (column 5, lines 19-26).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use sterilized packaging and an adhesive as the ‘345 publication is directed to a hemostatic gauze and the ‘519 patent teaches that is known to use hemostatic gauze on an adhesive backing and to be packaged in sterilized form. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘345 publication and the ‘519 publication are directed to hemostatic agent containing gauze to be applied to control bleeding. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a pressure sensitive adhesive to adhere gauze as the ‘345 publication teaches mounting the gauze substrate to a flexible substrate which may use a pressure sensitive adhesive to adhere the bandage to the skin [0068] and the ‘519 patent teaches using adhesive backing to attach a hemostatic gauze.
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 1-4, 6, 8-9, 11-16 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over
Claims 1-23 of U.S. Patent No. 9,603,964
Claims 1-23 of U.S. Patent No. 9,352,066
Claims 1-31 of U.S. Patent No. 9,072,806
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and disclosed patents are directed to hemostatic devices comprising a substrate, aluminosilicate/hemostatic material and a cross linkable binder immobilized to the substrate such that the hemostatic agent does not visibly separate from the substrate in the presence of water and is high G alginate. The device is taught to absorb blood and accelerate clotting in a bleeding wound.
Claims 1-4, 6, 8-9, 11-16 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over
Claims 1-22 of U.S. Patent No. 12,076,448
Claims 1-11 of U.S. Patent No. 11,559,601
Claims 1-27 of U.S. Patent No. 11,123,451
Claims 1-22 of U.S. Patent No. 10,960,101
Claims 1-19 of U.S. Patent No. 10,960,100
Claims 1-21 of U.S. Patent No. 9,333,117
Claims 1-29 of U.S. Patent No. 9,078,782
Claims 1-21 of U.S. Patent No. 8,846,076
Claims 1-28 of U.S. Patent No. 8,784,876
Claims 1-21 of U.S. Patent No. 8,460,699
in view of US 5,482,932 (previously applied).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and disclosed patents are directed to hemostatic devices comprising a substrate, aluminosilicate/hemostatic material and a cross linkable binder immobilized to the substrate such that the hemostatic agent does not visibly separate from the substrate in the presence of water as the binder is taught to be calcium alginate, an ionically crosslinked material per the instant specification [0070]. The device is taught to absorb blood and accelerate clotting in a bleeding wound. The instant application differs in that it requires alginate comprising a guluronic acid (G) content of at least about 50% by weight.
The ‘932 patent teaches alginate gels prepared by treating a water-insoluble or water-swellable alginate fibers, for example calcium alginate fibers with an aqueous solution of solubilizing salt such as sodium chloride. The new gels are easier to handle than other known alginate gels and are useful in wound dressing (abstract). Alginate may be high G or high M alginate. High-G alginate gel is taught (column 3, lines 15-26). Water insoluble alginate is taught (column 3, lines 50-60). The alginate gel can be provided dry and has higher water absorbency (column 4, lines 63-65). Alginate gels may contain a conventional preservative for medical alginates. Such materials may be dissolved or suspended so they become incorporated into the gel during its manufacture (column 5, lines 10-25). The gels are moldable and highly conformable and may be used as dressings on curved surfaces and may be used to pack wounds (column 5, lines 35-45).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use high G alginate as taught by the ‘932 patent for the alginate taught by the named patents because the ‘932 patent and the names patents are both directed to wound dressing comprising alginate. One of ordinary skill in the art would be motivated to use the alginate gels of the ‘932 patent on the device of the names patents because the ‘932 patent teaches the alginate gels are moldable, highly conformable to be used in wound and have higher water absorbency.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the claims distinguish over the prior art in that the binder of the ‘345 publication is glycerol or similar polyols and is not configured to immobilize the hemostatic material on the substrate when exposed to blood. The ‘345 publication does not provide motivation to prepare a hemostatic device having a binder configured to immobilize hemostatic material under blood exposure. The ‘345 publication teaches calcium alginate but is silent to controlling G-content to any particular level. The ‘932 fails to cure these deficiencies.
In response, the ‘345 publication teaches the binder to include calcium alginate [0073]. The ‘932 publication teaches alginate gels prepared by treating a water-insoluble or water-swellable alginate fibers, for example calcium alginate fibers with an aqueous solution of solubilizing salt such as sodium chloride. The new gels are easier to handle than other known alginate gels and are useful in wound dressing (abstract). Alginate may be high G or high M alginate. High-G alginate gel is taught (column 3, lines 15-26). It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use high G alginate as taught by the ‘932 patent for the alginate taught by the ‘345 publication because the ‘932 patent and the ‘345 publication are both directed to wound dressing comprising alginate. One of ordinary skill in the art would be motivated to use the alginate gels of the ‘932 patent on the gauze of the ‘345 publication because the ‘932 patent teaches the alginate gels are moldable, highly conformable to be used in wound and have higher water absorbency.
Applicant argues the ‘932 patent is directed to wound dressing intended to promote healing generally by maintaining a moist wound environment to prevent scabbing or cracking. In contrast the hemostatic devices are designed to arrest bleeding, often by absorbing moisture and promoting clot formation.
In response, the ‘345 patent is directed to a hemostatic device which uses calcium alginate as a binder, thus the ‘345 patent provides the motivation to use calcium alginate in a hemostatic device. Additionally, the ‘932 patent teaches the alginate gels may be provided dry and has a high water absorbency (column 4, lines 63-65) and to be packed into wounds (column 5, lines 35-45). Thus, absorption of the alginate gels and is known to be used on hemostatic devices.
Applicant argues the ‘932 patent is explicitly teaches away from the use of a substrate as receding claim 1 as it emphasizes that incorporation of alginate fibers into a fabric prevents sufficient swelling to form the desired fibrous gel. A person of ordinary skill in the art would not have been motived to apply the teachings of the ‘932 patent to a hemostatic device comprising a binder deposed on a substrate as doing so would frustrate the objective of the ’932 patent.
In response, the ‘345 publication teaches the use of the calcium alginate on the device as a binder. The ‘932 patent describes the use of high G for the calcium alginate in wound dressings, thus the ‘345 publication provides the motivation to use calcium alginate on the hemostatic device.
Applicant argues given the wet pasty and fibrous nature of the alginate material in the ‘932 patent a skilled artisan would not reasonably expect such material to allow direct contact between blood and hemostatic agent in a manner that accelerates clotting. One would expect this material to either way away upon exposure or impede hemostatic by blocking contact between the hemostatic agent and the wound surface.
In response, it is noted that the ‘932 patent teaches the gels may be provided dry and have high water absorbency (column 4, lines 63-65). Additionally, it appears Applicant is arguing unexpected results, however has not presented data. Attorney’s arguments may not take the place of factual evidence wherein factual evidence is required. The combination of reference teaches the claimed structure and thus would necessarily retain hemostatic agent absent factual evidence to the contrary. The ‘345 patent teaches the structure of the device comprising the hemostatic agent and calcium alginate. Applicant has presented no data regarding the comparison of high G to low G calcium alginate in the retention of the hemostatic agent.
Applicant argues the ‘932 patent acknowledges that alginate may be characterized as high-G or high M and expressly favors high M. Applicant’s invention runs counter to this teaching.
In response, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” (see MPEP 2123). Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).” (see MPEP 2141.02). The ‘932 patent teaches the use of both high and low G alginate (column 3, lines 15-26, Example 5).
Applicant argues they have unexpectedly found that crosslinked high G calcium alginate retains the hemostatic agent and permits direct contact between the hemostatic agent and blood thereby accelerating clot formation. Applicant’s use of high G alginate binder in its control dressing helps demonstrate the superiority of the claimed invention over any prior art calcium alginate dressing, which generally favor higher mannuronic acid content to facilitate ion exchange with sodium ions in wound fluid. High G alginates by contrast form stronger calcium crosslinks and resist dissolution.
In response, Applicant points to the instant specification, however the references are statements not factual data, wherein factual data is required. Applicant points to [0144]-[0146] which does demonstrate factual data however is only concerning a specific high G calcium alginate, and thus is not comparison date. It is further noted that the testing date provided by Applicant is not comparison between the low and high G calcium alginate and is not commensurate in scope with the instant claims. The instant claims are directed to at least about 50 wt% G content, wherein about allows for amounts above and below the recited 50 wt%, thus not requiring the G content to be more than 50 wt%. Additionally, the tested compositions are directed to 68% G and about 32% M. The results presented are not commensurate in scope.
Applicant argues the ‘519 patent does not cure the deficiencies of the ’345 publication and the ‘932 patent.
In response, Applicant’s arguments regarding the ’345 publication and the ‘932 patent are addressed above as first presented.
Double Patenting: Applicant request the rejections be held in abeyance.
In response, Applicant has presented no substantive arguments and thus the rejections are maintained for reasons of record.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613