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 .
Claims 4-6 are presented for examination.
Applicant’s amendments and response filed April 15, 2026 have been received and entered.
Applicant’s substituted specification filed April 29, 2026 has been received and entered.
Accordingly, the rejection made under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph (New Matter) as set forth in the previous Office action dated March 30, 2026 at pages 4-5 as applied to claim 3 is hereby WITHDRAWN because the applicant cancelled claim 3.
Accordingly, the rejection made under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph as set forth in the previous Office action dated March 30, 2026 at pages 5-6 as applied to claim 3 is hereby WITHDRAWN because the applicant cancelled claim 3.
Claim Rejections - 35 USC § 112
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 4-6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 is rendered indefinite and vague the phrase “negative cardiovascular effects associated with CVx in a human subject”. What are these negative cardiovascular effects caused by a CVx, such as Pfizer-BioNTech and Moderna (mRNA vaccine) and Novavax (protein subunit vaccine). The remaining claims 5-6 are rendered indefinite to the extent that they incorporate the above terminology.
Claims 4-6 are not allowed.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Little et al., “Zinc and cardiovascular disease”, Nutrition, Vol. 26, No. 10, pages 1050-1057 in view of Rath et al. (US 2007/0166400 A1) and further in view of Harris et al. (4,374,829) or Carini et al. (5,138,069).
Little et al. teach zinc is useful to treat cardiovascular disease.
The instant invention differs from the cited reference in that the cited reference does not teach the addition of a second agent, lysine, to treat cardiovascular disease. However, the secondary reference, Rath et al., teaches lysine is effective for alleviating or retarding cardiovascular diseases (see column 7, claim 6).
The instant invention differs from the cited references in that the cited references do not teach the dosage amounts of each individual active agent(s) together. However, to determine the dosage amounts may be calculated according to body weight, body surface area or organ sizes. Further refinement of the calculations necessary to determine the appropriate dosage involving each of the above active agent(s) is routinely made by those of ordinary skill in the art and is within the ability of tasks routinely performed by them without undue experimentation.
The instant invention differs from the cited references in that the cited references do not teach the combination use to mitigate negative cardiovascular effects associated with CVX i\in human. However, one skilled in the art would have assumed the combination of zinc and lysine, each agent known to treat cardiovascular diseases into a single combination, would be give an additive effect in the absence of evidence to the contrary.
The instant invention differs from the cited references in that the cited references do not teach a third agent, an ACE inhibitor or an angiotensin receptor blocker. However, the tertiary reference(s), Harris et al., teaches lisinopril (ACE inhibitor) is effective to treat cardiovascular diseases and Carini et al. teaches losartan (ARB) is effective to treat cardiovascular disease. Clearly, one skilled in the art would have assumed the combination of zinc and lysine with an ACE inhibitor or ARB, each agent known to treat cardiovascular diseases into a single combination, would be give an additive effect in the absence of evidence to the contrary.
Claims 4-6 are not allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629
Prosecution Insights