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 .
Status of claims
Claims 1 and 67-85 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 12/4/24 (2), The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 67-85 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dowling (WO 2018/184021).
Dowling teaches with regards to instant claims 1 and 67, a device (i.e., a product) comprising at least 2 compartments with a releasable, flowable product wherein the first compartment comprises a solution of an acidified hydrophobically-modified polymer which gels and the second product comprises a solution of a bicarbonate or carbonate salt at an alkaline pH (see pg 1, lines 23+), consisting of hydrophobic modifications which can be linear hydrocarbons from C6-C18(see pg 2, lines 6+, as required by instant claims 2 and 3) and the linear carbon groups selected from C12, C16 (as required by instant claim 5. The reference also teaches with regards to instant claim 25, that the concentration is from 0.1-2% (see claim 14) and that the hydrophobically-modified polymer comprises lactic acid, acetic acid having pH from 2-4.5 (see claims 15-16, as required by instant claim 27) from 03-0.5M (see pg 5, lines 13+, as required by instant claim 28) in the first compartment and the second compartment comprises sodium bicarbonate (as required by instant claim 30, see pg 5, lines 24+). Thus the hemostatic product comprising a device having at least two compartments each containing a releasable, flowable product: wherein a first compartment comprises a solution of an acidified cationic hydrophobically-modified polymer that creates hemostasis, and a second compartment comprises a solution of a bicarbonate or carbonate salt at an alkaline pH and an anionic polymer (i.e., an alginate as required by claim 37 and 40, see pg 6, lines 5+) wherein the cationic hydrophobically-modified polymer is hydrophobically-modified chitosan (see claim 3, as required by instant claim 39) for treating bleeding wounds in a body cavity (see claims 27-29, as required by instant claims 61, 84) that are not easily controlled by compression (see pg 1, as required by instant claim 620).
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
(a) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 67-85 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Dowling (WO 2018/184021)..
Dowling teaches with regards to instant claim 1, a device (i.e., a container) comprising at least 2 compartments with a releasable, flowable product wherein the first compartment comprises a solution of an acidified hydrophobically-modified polymer that creates hemostasis, and a second compartment comprises a solution of a bicarbonate or carbonate salt at an alkaline pH (see pg 1, lines 23+), consisting of hydrophobic modified polymer, (as required by instant claim 67) wherein the hydrophobically-modified polymer is an alginate (see pg 2, lines 25+, as required by instant claim 68, 81) or chitosan (as required by instant claims 68, 70 and 80, see pg 8, lines 23+ and pg 11, lines 5+) for treating bleeding wounds in a body cavity (see claims 27-29, as required by instant claims 84-85) dextran (as required by instant claim 73, see claim 21), wherein the hydrophobic modified polymer can be linear hydrocarbons from C6-C18 (see pg 2, lines 6+, as required by instant claims 75 and 76) and the linear carbon groups selected from C12, C16 (as required by instant claim 5, see pg 2, lines 10+). Additionally, Dowling teaches the grafts in length to be C8, C10 and C18 (see pg 10, lines 11+, as required by instant claims 75-78) wherein the hydrophobically-modified available functional groups on the polymer backbone is from 10-50% (as required by instant claim 10, see pg 2, lines 6+). The reference also teaches with regards to instant claim 83, that the concentration is from 0.1-2% (see claim 14 as required by instant claims 82-83)
Dowling teaches that grafts lengths can be from 8-20 with a density from 5-40% (see pg 10, lines 21+ and pg 12, lines 4+).
With regards to instant claim 69, Downing teaches that the polymer may be a synthetic polymer (see pg 7, lines 23+).
Thus, the claims would have been anticipated or obvious to one of ordinary skill in the art at the time the claimed invention was made.
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 and 67-85 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 15 of U.S. Patent Application No. 12,201,742.
Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows: Both sets of claims are drawn to a hemostatic product comprising a container having at least two compartments each containing a releasable, flowable product: wherein a first compartment comprises a solution having a concentration from about 0.1 wt % to about 5 wt % of an acidified hydrophobically-modified chitosan that creates hemostasis and has a pH of from about 2 to about 4.5, and a second compartment comprises a solution of a bicarbonate or carbonate salt at an alkaline pH, wherein the hydrophobic modifications of the chitosan comprise linear hydrocarbon groups in the range of C6 to C18.
The claims of the instant are to a product a hydrophobically-modified chitosan for treating wounds and the patented claims are directed to treating a cavity wound applying a hydrophobically-modified chitosan. It would have been obvious to one of ordinary skill in the art to have practiced the patented claims employing the instant claims with a reasonable expectation of success at the time of filing.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 9/23/26
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