DETAILED ACTION
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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/25/2026 has been considered by the examiner.
Status of the Claims
The response and claims filed 07/31/2026 are acknowledged.
Claims 96-116 are pending.
Applicant’s election of Group I, claims 96-108 and 114 in the reply filed on 07/31/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 109-113 and 115-116 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/31/2026.
Claims 96-108 and 114 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
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.
Claim 99 is 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 99 includes the limitation of wherein the sodium alginate has a chain length of between about 1,000 nm and about 3,000 nm. Neither the claim nor the specification indicates how this length was determined. Therefore, there is no objective metric disclosed or required by which the skilled artisan could understand how to avoid infringement.
Clarification is required.
Claim 100 is 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 100 includes the limitation of wherein the chitosan has a chain length of between about 2,000 nm and about 4,000 nm. Neither the claim nor the specification indicates how this length was determined. Therefore, there is no objective metric disclosed or required by which the skilled artisan could understand how to avoid infringement.
Clarification is required.
Claim 114 is 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 114 includes the limitation of a polymeric composition made by the method of claim 111. Claim 111 does not appear to be a method for making a polymeric composition. Further, claim 111 refers to the product of claim 96 so it is unclear how claim 111 was intended to further limit the subject matter of claim 96. For example, the skilled artisan cannot determine if the product of claim 114 requires the composition of claim 96 or requires the composition of claim 96 applied to a bleed site of the subject.
Clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 114 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). In the present case, claim 114 is directed to a composition made by the method of claim 111. Since claim 111 requires applying the composition of claim 96 to a subject (see claim 109), and the subject may be a human, claim 111 encompasses a human organism because claim 114 cannot be infringed without the subject to which the composition of claim 96 is applied.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 96-108 and 114 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-19 of US 12016968 in view of Zhu, US 20140178446 and Miller, US 20020028181.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach a polymeric composition comprising:
a. about 50% to about 94% by weight of water;
b. about 1% to about 5% by weight of sodium alginate having a molecular weight between about 500 kDa and about 900 kDa dissolved in a solvent to form a solution, wherein the solvent is water; and
c. about 5% to about 40% by weight of solid chitosan particles having an average particle size between about 50 mesh and about 500 mesh and an average degree of deacetylation of between about 75.0% to about 99.0%;
wherein the solid chitosan particles are dispersed in the solution of the sodium alginate to form the polymeric composition (claim 1). The limitations of claim 98 are found in reference claim 2. The limitations of claim 97 are found in reference claim 3. The limitations of claim 106 are found in reference claim 4. The limitations of claim 107 are found in reference claim 5. The modulus of reference claim 6 is within the range of instant claim 108. The limitations of claim 102 is found in reference claim 11. The limitations of claim 114 are found in reference claim 12 and 19. The limitations of claim 105 are inherent to the reference composition since the IR peaks correspond to alginate and chitosan. Since the reference composition is hemostatic and has the same arrangement of the same elements, it can achieve the limitations of claim 101 if used in the same way. The limitations of claim 99 are present in the reference composition since the reference sodium alginate has the same molecular weight.
The reference claims do not teach the chain length of claim 100. However, Zhu teaches chitosan having a molecular weight of 1000 kDa and a degree of deacetylation in the claimed range was known and effective for hemostasis. See Zhu, e.g., 0098, 0120, 0053-0054. This molecular weight chitosan has a chain length in the claimed range. See Specification, e.g., 0045.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify compositions within the scope of the reference claims using a chitosan material having a molecular weight of about 1000 kDa as taught by Zhu with a reasonable expectation of success. The skilled artisan would have seen this modification as the selection of a known chitosan material based on its known suitability as a hemostatic agent. The skilled artisan would have had a reasonable expectation of success since Zhu also teaches chitosan composition for hemostatic use.
The reference claims do not expressly teach the viscosity recited in claim 103 or the pH of claim 104. However, Miller cures these defects.
Miller teaches compositions which promote hemostasis (Miller, e.g., 0002), wherein the composition has a viscosity optimized to balance desired bioadhesiveness and ease of delivery, e.g., viscosity up to 2000000 cps, e.g., in the range of about 500 cps to about 1500000 cps, e.g., about 1000 cps to about 500000 cps (Miller, e.g., 0090-0092). 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). MPEP 2144.05. The claimed range is within the range suggested by the prior art.
Further, Miller teaches the pH of about 7 for biocompatibility (Miller, e.g., 0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify reference compositions to have a viscosity and pH suggested by Miller with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to optimize the properties for biocompatibility and to balance adhesiveness with ease of delivery in the same way suggested by Miller. The skilled artisan would have had a reasonable expectation of success since Miller teaches these properties to improve delivery of hemostatic compositions.
Accordingly, the subject matter of claims 96-108 and 114 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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