DETAILED ACTION
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 .
Status of Claims
Claims 39-51 are pending in the instant application. Claims 39-46 are withdrawn.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on September 25th, 2025 has been entered.
Restriction/Election
Search and examination has been limited as previously discussed in the Office action dated November 18th, 2024. Examination is limited to the extent that claims 47-51 are readable on elected group II, with the elected anticoagulant, rivaroxaban. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration, claims 39-46 are withdrawn.
Withdrawn Rejections
Applicant’s arguments, see pages 4-7 of the remarks, filed September 25th, 2025, with respect to the 35 USC 103 rejection of claims 47-49 over Tumlin in view of Vaidya and Petreofsky have been fully considered and are persuasive. The 35 USC 103 rejection of claims 47-49 has been withdrawn.
On p. 5 of the remarks, Applicant argues that Vaidya teaches muscle cramps, but does not mention that the muscle cramps are due to exercise. Applicant further argues that muscle cramps and exercise-associated DOMS are different conditions with different etiologies.
Examiner finds this argument persuasive.
Response to Remarks
Applicant’s arguments and amendments, filed September 25th, 2025, with respect to the 35 USC 102 rejection of claims 50-51 over Clauwe have been fully considered and are not persuasive. Applicant’s arguments will be addressed as they relate to the rejection below.
On p. 1 of the remarks, Applicant argues that increased ATP production does not necessarily flow from the teaching of Caluwe because critical differences exist in the dosing regimens of the present application. Applicant argues that the in contrast to Caluwe, the present application uses a daily dosing regimen disclosed on page 10 of the instant specification. Applicant alleges that the inherency argument fails because Caluwe teaches a fundamentally different dosing regimen (2000 μg MK-7 thrice weekly + 10 mg rivaroxaban daily) compared to daily dosing regimen (10-2000 μg/day MK-7 + 5-30 mg/day rivaroxaban) in the present application. Applicant asserts that differences in regimen creates different pharmacokinetic profiles with different peak and trough concentrations and that there is no evidence that these different dosing regimens would necessarily produce identical cellular ATP effects.
However, instant claim 50 requires the administration of “a therapeutic amount of vitamin MK-7”. The instant specification defines a therapeutically effective amount of vitamin K as follows (instant specification page 10, paragraph 2):
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As such, Caluwe teaches a dosing regimen that falls within the teachings of the instant disclosure (between 70 and 14000 μg/week).
However, even if the dosing regimen differed from the art, specification limitations may not be incorporated into the claims. In the instant case, the therapeutically effective amounts that correspond to the dosages are not present in instant clam 50. If Applicant is taking the position that there is a specific dosage of vitamin K and rivaroxaban to be used, this limitation should be recited in the claim. See MPEP 2111.01: “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004) (discussing recent cases wherein the court expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment); E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (“Interpretation of descriptive statements in a patent’s written description is a difficult task, as an inherent tension exists as to whether a statement is a clear lexicographic definition or a description of a preferred embodiment. The problem is to interpret claims ‘in view of the specification’ without unnecessarily importing limitations from the specification into the claims.”); Altiris Inc. v. Symantec Corp., 318 F.3d 1363, 1371, 65 USPQ2d 1865, 1869-70 (Fed. Cir. 2003) (Although the specification discussed only a single embodiment, the court held that it was improper to read a specific order of steps into method claims where, as a matter of logic or grammar, the language of the method claims did not impose a specific order on the performance of the method steps, and the specification did not directly or implicitly require a particular order).
On p.2 of the remarks, Applicant argues that the “discovery of new property” argument does not apply to the instant disclosure as instant claims 50-51 are not product claims. Applicant further argues that Caluwe concerns a very specific indication in patients and that the dosing regimens of Caluwe are specifically designed for a select grouping of patients.
In response, firstly, the dosing regimen of Caluwe fall within the instant disclosure, see argument above. Secondly, as stated in the previous office action, the only active step of the claim is an administration and the limitation regarding “increasing ATP product” which represents intended effect rather than a material step that must be met. As the same composition, vitamin MK-7 and rivaroxaban are being administered to the same population, a cell, the intended effect will naturally flow from the teachings.
On p. 3-4 of the remarks, Applicant argues that the “whereby” clause has patentable weight and must not be disregarded. Applicant argues that in the instant disclosure the “whereby” clause is more than a statement of intended purpose and that is represents a specific, measurable therapeutic outcome that would not necessarily result from the recited manipulative step of any other limitations of the claim.
Such is not found persuasive because, the clause of the instant disclosure “whereby reactive oxygen species are reduced or ATP production is increased by at least 10%”, simply expresses the intended result of a process step positively recited. The process step being the administration of vitamin K and rivaroxaban to a cell and the intended result being that ATP production is increased by at least 10%.
Maintained Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 50-51 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caluwe R et al. (Clin Kidney J. 2016 Apr;9(2):273-9).
Clauwe teaches a method of treating patients on chronic haemodialysis, with non-valvular atrial fibrillation, using a combination of Rivaroxaban 10 mg od + MK-7 2000 μg 3x/w (page 275, left column, paragraph 1). In Table 1, Caluwe discloses that MK-7 can be administered at various does, each targeting specific cardiovascular disease states: 180 ug daily for arterial stiffness, 375 ug daily for arterial stiffness, mineral density, and insulin sensitivity, and 2000 three times weekly for progression of thoracic aorta and arterial stiffness (page 276).
The prior art is silent regarding "increasing ATP production". However: " increasing ATP production "will inevitably flow from the teachings of the prior art (see above rejection), since the same composition (vitamin K2 and rivaroxaban) is being administered to the same subjects (any cell).
In other words, even though the prior art is silent regarding " increasing ATP production, by practicing the method taught by the prior art: "the administration of a composition of vitamin K2 and rivaroxaban ", one will also be "increasing ATP production,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("increasing ATP production") of the method taught by the prior art ("the administration of a composition of vitamin K2 and rivaroxaban to any possible cell").
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Further, the only active step of the claims is an administration and the limitation regarding “increasing ATP production” which represents intended effect rather than a material step that must be met. See, for instance, Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) where the Court addressed preamble language “for treating cancer” as expressing an intending result that does not result in a manipulative difference.
Furthermore, regarding claim 50, the phrase “whereby reactive oxygen species are reduced or ATP production is increased by at least 10%.”” is a nonlimiting statement of intended purpose. Generally, a “wherein”, “whereby” or “thereby” clause in a method claim “is not given weight when it simply expresses the intended result of a process step positively recited.” Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003). See MPEP 2111.04(I).
As the administration of a composition of vitamin K2 and rivaroxaban is taught by Clauwe, as seen above, instant claims 50-51 are anticipated by the prior art teaching.
New 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.
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.
Claim(s) 47-49 are newly rejected under 35 U.S.C. 103 as being unpatentable over Vermeer et al (US 2016/0310445, as cited on the IDS dated 09/20/2021) in view of Tak et al (BMJ Case Rep 2013. doi:10.1136/bcr-2013-201488).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Vermeer teaches vitamin K for use in a method for preventing and/or decreasing and/or counteracting thrombosis risk, in mammalian subjects, preferably human subjects (claim 1). Vermeer teaches that the vitamin K is a menaquinone, preferably a long chain menaquinone, MK-7 (claim 3). Vermeer also teaches that the vitamin K is for administration in combination with factor Xa inhibitors and/or heparin-related anticoagulants (claim 15). Further, Vermeer teaches that the factor Xa inhibitor is rivaroxaban (paragraph [0068]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that the mammals to be treated with the vitamin K2 and rivaroxaban composition also experience delayed onset muscle soreness associated with exercise.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Tak teaches that leg pain after heavy repetitive exercise is a symptom of thrombosis. Tak teaches that a patient developed leg pain and swelling after walking for exercising (page 1, right column, paragraph 1). Tak teaches that the patient was diagnosed with thrombosis (summary). Further, Tak teaches that thrombosis should be kept as differential in patients who develop lower leg swelling and pain after heavy repetitive exercise (page 2, right column, paragraph 4).
Regarding claim 47, one of ordinary skill in the art would have been motivated to administer vitamin K2 and rivaroxaban as a method of treating delayed onset muscle soreness as Vermeer teaches that the combination treats thrombosis and Tak teaches that leg pain after exercise is a symptom and should be used as a diagnostic tool of thrombosis.
Regarding claims 48-49, as seen above, Vermeer teaches that the anticoagulant is rivaroxaban.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699