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 .
Applicants' arguments, filed 09/17/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112—New by Amendment
New Matter
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.
1) Claims 27-30 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite the wherein clause “wherein a sample of bodily fluid is taken from the subject has less than 4.4 mg/L of Selnoprotein P and/or fragments thereof”. The clause reads on a method step to be performed by the artisan in conjunction with administering selenium to patients with heart failure. However, this concept is not supported by the disclosure as originally filed. The bodily fluid samples are disclosed in the specification as a means for identifying a patient, i.e., it is evidence of risk of re-hospitalization (see p. 11, lines 9-12). Once the patient is identified, the patient is administered selenium. The clause, taken out of context, reads on a method not disclosed in the specification and is therefore new matter.
Indefiniteness
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.
2) Claims 27-30 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.
The phrase “wherein a sample of bodily fluid is taken from the subject has less than 4.4 mg/L of Selnoprotein P and/or fragments thereof” causes the claim to be indefinite insofar as it is unclear at what point, i.e. when, the bodily fluid is taken. It is unclear whether the task is performed before or after selenium is taken.
Since the specification discloses that the threshold range “between 2.2 and 4.4 mg/L” are “related to the calibration method mentioned in the examples” (p. 11, lines 9-12), the phrase will be interpreted as a condition of heart failure.
Claim Rejections - 35 USC § 101--Previous
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.
Claims 16, 18-20, 24-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) an “administering” step—instructing a doctor to administer the selenium to his patient—(2) a “determining” step—telling the doctor to measure the resulting metabolite levels, i.e. Selenoprotein P and/or fragments thereof, in the patient's blood—and (3) a “correlating/wherein” step—listing risk factors, i.e. cardiovascular event, worsening heart failure, mortality or hospitalization, associated with levels of Selenoprotein P. This judicial exception is not integrated into a practical application because limiting drug administration to this patient population does no more than simply refer to the relevant pre-existing audience of doctors who used selenium to treat patients suffering from heart failure. The combination amounts to nothing significantly more than instructing doctors to apply the applicable laws when treating their patients. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because measuring metabolite levels of Selenoportein P is a well-understood, routine conventional activity previously engaged by others in the cardiovascular field. See Strouss et al., teaching “We observed significantly increased plasma levels of SeP [Selenoprotein P]in patents with concomitant HF [heart failure], as compared to levels in patients without HF . . . In an analysis in which all subjects with a known concentration of SeP were included (N=165), the presence of SeP levels ≥ 8.5 mg/ml was associated with a 3.51-fold increased risk of HF” (p. 8/17, sec. 3.6).
Claim Rejections - 35 USC § 102/103--Previous
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.
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.
1a) Claim(s) 16, 18-20, 25 remain rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Raygan et al., (British Journal of Nutrition, July 2018). This rejection also applies to newly added claims 27-30.
Raygan et al. teaches the effects of selenium (Se) supplementation “in patients with congestive heart failure (CHF)”, concluding, “[o]verall, our study supported that Se supplementation for 12 weeks to patients with CHF had beneficial effects on insulin metabolism and few markers of cardio-metabolic risk” (Abstract).
Here, the cardiovascular event and mortality is not a stroke or related to a stroke, as per claim 25. Raygan et al. does not teach stoke.
The subjects of the study “were randomly allocated into two groups to take either 200 µg/d of Se as Se yeast (n 26) or placebo (n 27) for 12 weeks” (Id.).
The prior art is anticipatory insofar as it teaches administering selenium to patients having heart failure. Note: Selenoprotein P is inherent to the patient and varies from patient to patient, especially depending on diet. However, the heart failure patient, regardless of their Selenoprotien P levels, would have been included in the method of Raygan et al.
Given the patients state of being, i.e. heart failure, the artisan would have expected the patients to be at risk for a cardiovascular event, worsening heart failure, mortality, and re-hospitalization (see also Technological Background below).
Furthermore, concerning the concentration of Selenoprotein P(SeP) and/or fragments thereof, the prior art does not limit administration based SeP and or fragments thereof. Accordingly, it would have been obvious to administer selenium to these patients in the method of Raygan et al., regardless of their SeP levels, simply because they present with heart failure.
1b) Claim(s) 24 and 26 is/are rejected under 35 U.S.C. 102/103 as being unpatentable over Raygan et al., (British Journal of Nutrition, July 2018) as applied to claim 16 above, and further evidenced by Graves (The ZRT Laboratory Blog, 2015).
Graves evidences the contents of Se yeast provided in Raygan et al., which Graves teaches “consists predominantly of selenomethionine (between 60 and 80%), but also has small amounts of selenocysteine, methylselenocysteine and gamma-glytamyl Se-methylselenocysteine. Reputable manufactures ensure that the majority (at least 90%) of the selenite is organically bound to the yeast; otherwise, the product may simply contain a mixture of inorganic selenite and yeast” (see Seleniuim-Enriched Yeast).
Accordingly, the Se yeast of Raygan et al. would have provided selenomethionine and selenite, as per claim 24, to the patient.
Concerning claim 26, Raygan et al. teaches, “Supplementation with combined Se and coenzyme Q10 for 48 months to elderly individuals decreased CRP and sP-selectin levels” (p. 38, bottom of left column through right column).
Response to Arguments
i. Applicant argues, “even if the claims are determined to activate the judicial exception and enter the 101 guidelines analysis, the USPTO guidelines in its Vanda Memo explains that if the claims also recite a specific active step, then they include ‘something more’ and sufficient to exit the 101 analysis as a patent eligible claim” (p. 5).
The Examiner disagrees.
There is nothing in the Vanda memo specifically relating the concept of “something more” to a specific active step.
The application at issue in Vanda (Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)) is distinguished from the present application insofar as the use of iloperidone was novel. The notion of being “directed to” correlates to a new drug application, which is not applicant’s situation. The court in Vanda stated, “First, the claims in Mayo were not directed to a novel method of treating a disease” (p. 29); and “[t]o further underscore the distinction between method of treatment claims and those in Mayo, the Supreme Court noted that ‘[u]nlike, say, a typical patent on a new drug, the patent claims do not confine their reach to particular applications of those laws.’” (p. 29, last paragraph). It is clear to the Examiner that novelty played a significant part in establishing the court’s opinion.
Like the claims in Mayo, the claims of the instant application are not directed to a novel method of treating a disease. Again, the administering step simply identifies a group of people who will be interested in the correlations, namely, doctors who used selenium to treat patients suffering from heart failure. Doctors had been using selenium supplementation for this purpose before applicant’s filing.
ii. Applicant argues, “administering selenium to patients with heart failure does not meet all the requirements of the claim because the claims require that the patients have more than just heart failure. The prior art fails to teach that the patients also had enhanced risk . . . or . . . had levels of Selinoprotein P and/or fragments thereof below 4.4 mg/L” (p. 8)
The Examiner disagrees.
The heart failure patients of Raygan et al. are at risk for hospitalization insofar as they’ve had heart failure (see Bui et al. below). Because selenium was administered to these patients, the prior art anticipates administering selenium to said subject.
The determining/correlating steps are simply ways to identify the patient. Because the prior art identifies the same patient, i.e., patients presenting with failure patient, administration to these patents would have been obvious in view of Raygan et al.
Nonstatutory Obvious-type 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 16-20, 24-26 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,844,812. This rejection also applies to newly added claims 27-30. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a method of treating a subject with heart failure by administering selenium to said subject.
Technological Background
1) The prior art made of record is considered pertinent to applicant's disclosure Bui et al., (Nat Rev. Cardiol. 2011). Bui et al. is pertinent for teaching the epidemiology and risk profile of heart failure (HF) (Ti). Bui et al. teaches, “HF still carries substantial morbidity and mortality, with 5-year mortality that rival those of many cancers. HF represents a considerable burden to the health-care system, responsible for costs of more than $39 billion annually in the USA alone, and high rates of hospitalizations, readmissions, and outpatient visits” (Abstract).
2) The prior art made of record is considered pertinent to applicant's disclosure PharmaNord., (www.pharmanord.com, 2016). PharmaNord is pertinent for teaching, “We also need selenium to make the antioxidant enzymes that protect the cells against harmful free radicals and are part of the mechanism that activates the antioxidant effect of CoQ10” (first paragraph). PharmaNord also teaches use of administration of KiSel-10 (a combination of CoQ10 and selenium) to elderly patents for a 48-month period (see The KiSel-10 Study). Results of the combination included “A reduction in cardiovascular deaths (54%)”, “A reduction in the levels of heart disease biomarkers” and “Better cardiac function scores on echocardiograms” (Id.).
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick F. Krass can be reached (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/WALTER E WEBB/ Primary Examiner, Art Unit 1612