DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 12/19/2025, has been entered.
Status of Application
Receipt of the amendments to the claims and the applicant arguments/remarks, filed 12/19/2025, is acknowledged.
Applicant has previously elected with traverse the invention of Group I, claims 1-3 and 8-21, drawn to a particulate powder composition comprising anhydrous salt ferrate compound and an insoluble cation exchange material.
Claims 1-21 are pending in this action. Claims 1-3, 8, 15, 18 have been amended. Claims 4-7 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1-3 and 8-21 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a divisional of U.S. Patent Application No. 16/274,406, filed February 13, 2019 and now issued as U.S. Patent No. 11,241,386.
Information Disclosure Statement
The information disclosure statement, filed 08/25/2025, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
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 1-3 and 8-21 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly amended independent claims 1, 8, 10, 15, 18 disclose wound sealing compositions comprising a particulate powder comprising a mixture of an anhydrous salt ferrate compound and an effective amount of an insoluble cation exchange material.
The written description requirement for a claimed genus (here as a particulate powder) may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. MPEP §2163.
In the present case, it is noted that the instant specification teaches the use of powders consisting essentially of a substantially anhydrous salt ferrate compound with an effective amount of an insoluble cation exchange material (Summary of Invention), but does not provide any definition/clarification for the terms “consisting essentially” and/or “substantially”. Further, it is noted that the example provided in the instant specification teaches mixing the ferrate having a particle size of 2 mm or less in diameter with dried particulate resin at a ratio of 1:2 ferrate:hydrogen resin (example 1), i.e., a preparation of a particulate powder consisting of said compounds. No information is provided in the instant specification what compounds must be excluded and/or can be included into the prepared particulate powder to be used in wound sealing compositions.
The present specification provides no disclosure beyond the statement, that would have been amenable for use in the present invention, nor does it teach the specific structure, physical properties or a method of identification of compounds that can be included in claimed compositions. To this point, it is noted that a wish or plan for obtaining the chemical invention as claimed does not provide adequate written description of a chemical invention. Rather, a precise definition, such as by structure, formula, chemical name or physical properties, is required. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004).
While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for claim limitations must arise from either an explicit or implicit suggestion by the disclosure to show that such a concept as claimed was actually in possession of applicant at the time of the invention. For the reasons provided supra, the applicant has failed to provide the necessary teachings, by describing the claimed invention with all of its limitations using such descriptive means that fully set forth the claimed invention, in such a way as to reasonably convey to one skilled in the relevant art that applicant had possession of the entire genus of drugs. Therefore, it is the examiner’s position that the instant specification does not provide required written description of the claimed invention.
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 1-3 and 8-21 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 1 recites the limitation “the powder contains no particles of the anhydrous salt ferrate compound and the insoluble cation exchange material having a particle diameter of 158 microns or more” that is not reasonably clear. In the present case, it is unclear if recited numerical limitation “particle diameter of 158 microns or more” refers to both types of recited particles, or only to particles of insoluble cation exchange material. Similar is applied to claims 2, 3. Clarification is required.
Claim 8 recites the limitation “powder comprising an anhydrous salt ferrate compound and a ground insoluble cation exchange material” that is not reasonably clear. Does this limitation imply that an anhydrous salt ferrate compound is present not in a particulate form, e.g., as bound to particles of ground insoluble cation exchange material? Similar is applied to claims 9-11, 15, 18. Clarification is required.
Claims 10, 18 recites the limitation “more than 50% of the particles” that is not reasonably clear. In the present case, it is noted that the instant specification uses the term “majority of particles” as 65%, or 80%, or 83% (Para. 0050, 0051 in US 2022/0151930). No information is provided in the instant specification regarding the “particle size of more than 50% of the particles”. Therefore, clarification is required.
Claims 12-14, 16-17, 19-20 are rejected as being dependent on rejected independent claims 1, 8, 10, 15, 18 and failing to cure the defect.
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 obviousness-type 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); 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.
Claims 1-3, 8-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,241,386.
Although the conflicting claims are not identical, they are not patentably distinct from each other because prior patents also claim: A wound sealing composition comprising a particulate powder consisting essentially of mixture of a substantially anhydrous salt ferrate compound and an effective amount of an insoluble cation exchange material, wherein at least 90% of the particles in the powder have a particle size of 77.4 microns or less. In the present case, the instant claims are merely broader than prior patent application claims that include additional limitation (i.e., the use of anhydrous salt ferrate compound; and 90% of the particles in the powder have a particle size of 77.4 microns or less) and therefore are more specific.
Response to Arguments
Applicant's arguments, filed 12/19/2025, have been fully considered. Any rejection or objection not reiterated in this action is withdrawn. New rejections have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant’s request to hold double patenting rejection in abeyance it is noted that the filing of a terminal disclaimer cannot be held in abeyance since that filing "is necessary for further consideration of the rejection of the claims" as set forth in MPEP 804(I)(B)(1): "As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application's claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated."
Further, the applicant is advised to clarify the claim language to clearly set forth the metes and bounds of the patent protection desired/requested, and clearly point out the patentable novelty of the claimed invention to place the application in condition for allowance. As stated previously, the main purpose of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent; and to provide a clear measure of what the applicant regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability. MPEP 2173.
Furthermore, it is noted that withdrawn claims need to be also amended to be rejoined (see Requirement for Restriction, filed 03/10/2023).
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615