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
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 11/26/2025.
As filed, claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/18/2025 has been considered by the Examiner.
Terminal Disclaimer
The terminal disclaimer filed on 11/26/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12/383,531, as well as any patent granted on application No. 19/000,102 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 11/26/2025, with respect to claims 1-20, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112(b) indefinite rejection of claim 3 is maintained because the phrase, “the field”, still lacked antecedent basis.
The § 112(b) indefinite rejection of claim 20 is withdrawn per amendments.
The nonstatutory anticipation-type double patenting (ODP) rejection of claims 1, 3-9, and 11-18 by conflicting U.S. Patent No. 12,383,531 is withdrawn per filing and approval of the abovementioned terminal disclaimer.
The provisional anticipation-type double patenting (ODP) rejections of claims 1, 3-9, and 11-18 by co-pending application No. 19/000,102 is withdrawn per filing and approval of the abovementioned terminal disclaimer.
The nonstatutory obviousness-type double patenting (ODP) rejections of claims 1-20 by co-pending application No. 18/703,760 is maintained because this ODP rejection is not the only rejection remaining. Without filing and approval of a terminal disclaimer, the ODP rejection is maintained.
The nonstatutory obviousness-type double patenting (ODP) rejections of claims 1-20 by co-pending application No. 19/000,102 is withdrawn per filing and approval of the abovementioned terminal disclaimer.
The claim objection of claims 12 and 16 is withdrawn per amendments.
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.
Claim 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the claim is dependent of claim 1 and recites the phrase, “the field” wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” field in claim 1 or 3. Without antecedent basis, the claim is rendered indefinite.
Nonstatutory 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.
The instant claims are drawn to a method of treating envenomation via a number of compounds depicted in claim 1 or 7.
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
18/703,760
1-17, 20, 21, 26, and 29-37
Yes
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned co-pending applications are drawn to a composition comprising sPLA2 inhibitors (e.g. varespladib, methyl varespladib, AZD2716, compound 4, etc.) and optionally at least one antivenom, antibody, antibody fragment, metalloprotease inhibitor, etc. for treating wound caused by envenoming by snake, or envenomation by hymenoptera, etc.
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned co-pending applications did not described abovementioned composition in a method of treatment-type claim.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness - none
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other because they are drawn to the same composition having the same therapeutic utility (e.g. treating envenomation by snake, envenomation by hymenoptera, etc.). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned co-pending applications.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that the therapeutic utility of the composition of the abovementioned co-pending applications is excluded as the therapeutic utility of the instant process of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant process and that of the conflicting claims of the abovementioned co-pending applications to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy 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.
Conclusion
Claims 1-20 are rejected.
THIS ACTION IS MADE FINAL. 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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621