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 .
DETAILED ACTION
Claims 18-24 are under consideration.
The instant application is a divisional (DIV) of Application No. 17/549,131 filed December 13, 2021 (now U.S. Patent No. 11,998,656), which is a DIV of Application No. 15/258,549 filed September 7, 2016 (now U.S. Patent No. 11,229,720).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 26, 2024, February 27, 2025 and November 23, 2025 were considered.
Claim Objections
Claims 18 and 22-24 are objected to because of the following informalities:
Claim 18 recites “a hemostatic composition comprising a hemostatic composition comprising”. One of the duplicative recitations should be deleted.
Claim 22: “a ratio” is properly “the ratio” because antecedent basis is implicit.
Claim 22 is grammatically incorrect. Presumably “is” should be inserted before “from”.
Claims 23, 24: “a” should presumably be inserted before “particle size”.
Claim 24: “a” should be inserted before “powder” consistent with claim 23.
Appropriate correction is required.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 15/258,549.
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 21-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 21 recites a composition comprising about 90% fibrinogen, about 8% thrombin and about 2.5% calcium chloride. Notwithstanding the fact that the qualifier about permits some tolerance, 90 + 8 + 2.5 = 100.5. Because the claimed amounts exceed 100% and because the instant specification fails to define the term about, it is unclear how to interpret the metes and bounds of an impossible composition. Claim 22 is included in this rejection because it depends from claim 21 and because it does not remedy the noted ambiguity.
Claims 23 and 24 recite particle sizes predominantly in a range. The term “predominantly” is a relative term which renders these claims indefinite because the term “predominantly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Because it is unclear what threshold is required to achieve predominance, the metes and bounds of the particle size cannot be ascertained.
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 of this title, 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 18, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2013/0316974, published November 28, 2013, IDS reference filed April 26, 2024) in view of Sakamoto et al. (US 4,655,211, published April 7, 1987) and Stilwell et al. (US 5,484,913, published January 16, 1996, IDS reference filed April 26, 2024).
Wang teaches oxidized regenerated cellulose (ORC) hemostatic powders and a method of treating a wound by applying the hemostatic powders onto and/or into the wound of a patient (title; abstract; claims, in particular 1, 16). ORC comprises cellulose fibers (paragraph [0031]). The powders may be prepared by a powder agglomeration process (paragraph [0039]).
The powders may further comprise an additive such as a calcium salt or/and a hemostasis promoting agent such as thrombin or/and fibrinogen (claim 4; paragraph [0032]; Example 6).
The powders may have a largest dimension less than 500 microns (paragraph [0029]), as required by instant claims 23, 24. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.
Wang does not specifically teach at least partially integrated (meaning attached or coated as exemplified at paragraph [090] of the instant specification) agglomerated ORC fibers, fibrinogen and thrombin as required by claim 18.
This deficiency is made up for in the teachings of Sakamoto and Stilwell.
Sakamoto teaches a hemostatic agent comprising a biodegradable carrier in the shape of a flake or fiber having thrombin and factor XIII fixed thereto by bonding or adsorbing (at least partially integrated) (title; abstract; claims; column 4 through column 5, line 28). Carrier materials include fibrinogen or/and oxycellulose (claim 5; Example 7). In example 7, factor XIII and thrombin were adsorbed in a fiber aggregation of neutral oxycellulose obtained by washing with calcium acetate.
Stilwell teaches a calcium-modified oxidized cellulose hemostat providing faster hemostasis impregnated with acid-sensitive materials inclusive of thrombin or/and fibrinogen (at least partially integrated) (title; abstract; claims, in particular 1, 6, 15-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the agglomerated ORC cellulose fiber hemostatic powders of Wang to further comprise hemostasis promoting agents inclusive of thrombin and fibrinogen adsorbed into or/and impregnated within (at least partially integrated) as taught by Sakamoto and by Stilwell in order to provide faster hemostasis. There would be a reasonable expectation of success because Wang embraces the presence of additives inclusive of thrombin and fibrinogen as additives.
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2013/0316974, published November 28, 2013, IDS reference filed April 26, 2024) in view of Sakamoto et al. (US 4,655,211, published April 7, 1987) and Stilwell et al. (US 5,484,913, published January 16, 1996, IDS reference filed April 26, 2024) as applied to claims 18, 23 and 24 above, and further in view of Li et al. (CN 101890181 A, published November 24, 2010, as evidenced by the Google translation, IDS references filed April 26, 2024).
The teachings of Wang, Sakamoto and Stilwell have been described supra.
They do not teach tris as required by claim 19.
They do not teach calcium chloride as required by claim 20.
They do not teach a fibrin sealant powder comprising about 90 wt% fibrinogen, about 8 wt% thrombin and about 2.5 wt% calcium chloride as required by claim 21.
These deficiencies are made up for in the teachings of Li.
Li teaches a fibrin glue powder comprising 31.3 to 95.5% fibrinogen, 2.3 to 9.7% thrombin, sodium chloride, sodium acetate, 1.2 to 26.8 wt% calcium chloride and tris (title; abstract; claims, in particular 3), as required by instant claims 19-21. The fibrin glue can be directly used without preparation, meaning it can be sprayed on a wound surface in a powder shape, saving time and bringing great convenience (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the thrombin and fibrinogen impregnated agglomerated ORC cellulose fiber hemostatic powders of Wang in view of Sakamoto and Stilwell by impregnating the ORC with the fibrin glue powder of Li because this glue powder can be directly used without further preparation. There would be a reasonable expectation of success because Wang embraces the presence of additives inclusive of calcium salts, thrombin and fibrinogen as additives.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2013/0316974, published November 28, 2013, IDS reference filed April 26, 2024) in view of Sakamoto et al. (US 4,655,211, published April 7, 1987) and Stilwell et al. (US 5,484,913, published January 16, 1996, IDS reference filed April 26, 2024) as applied to claims 18, 23 and 24 above, and further in view of Li et al. (CN 101890181 A, published November 24, 2010, as evidenced by the Google translation, IDS references filed April 26, 2024) as applied to claims 19-21 above, and further in view of Gorman et al. (US 2004/0101546, published May 27, 2004).
The teachings of Wang, Sakamoto, Stilwell and Li have been described supra.
They do not teach a weight ratio of the sealant powder to the ORC of about 1:1 to about 10:1 as required by claim 22.
This deficiency is made up for in the teachings of Gorman.
Gorman teaches a hemostatic wound dressing comprising aldehyde modified polysaccharide and hemostatic agents inclusive of fibrinogen or/and thrombin covalently conjugated thereto (title; abstract; claims, in particular 1, 2, 13; Examples). The substrate comprises about 0.001 to 50 wt% of the hemostatic agent (claim 14). The hemostatic agent is dispersed at least partially through said substrate (claim 21). The substrate may be in the form of a powder (claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fibrin glue powder impregnated agglomerated ORC cellulose fiber hemostatic powders of Wang in view of Sakamoto, Stilwell and Li to comprise about 0.001 to 50 wt% of the fibrin glue as taught by Gorman because these amounts of hemostatic agents may be dispersed at least partially through polysaccharide powder substrates. Because the fibrin glue powder impregnated agglomerated ORC cellulose fiber hemostatic powders rendered obvious by the prior art requires two components, the glue and the ORC, and the glue may be present from about 0.001 to 50 wt%, it necessarily follows that the ORC comprises the balance of the composition, rendering obvious ratios as instantly claimed (e.g., 50 wt% implies a 1:1 ratio). See MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schaufler (US 2002/0164322) teaches a suspension comprising fibrinogen and thrombin and a method of coating a carrier with the suspension; exemplary carriers include ORC (title; abstract; claims; paragraph [0351]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner , Art Unit 1600
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