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 .
Election/Restrictions
Applicant’s election without traverse of Group I, encompassed by claims 1-5, 9-10, 12-16, 18-19, 21-22, and 27-28, previously drawn to a method of treating or preventing endothelial dysfunction, increasing heme oxygenase-1, or activating Nrf2, in the reply filed on May 6, 2026, is acknowledged.
Applicant has not pointed to any errors in Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant further elected the following species, without traverse, as described below: a. a single polyunsaturated fatty acid (FA): Applicant elects docosahexaenoic acid (DHA);
b. a single linoleic acid (LA) derivative: Applicant elects 9-hydroxyoctadecadienoic acid (9-HODE);
c. a single DHA derivative: Applicant elects 14-hydroxydocosahexaenoic acid (14-HODE).
Applicant has not pointed to any errors in Examiner’s analysis of the different species. The requirement is still deemed proper and is therefore made FINAL.
In the claims as filed on 05/06/2026, applicants have amended claims 1, 2, 5, 10, 12, and 14; cancelled claims 6-8, 11, 17, 20, 23-26, 29 and 30; and added no new claims. Therefore, claims 1-5, 9-10, 12-16, 18-19, 21-22, and 27-28 are currently pending and claims 1-5, 9-10, 12-16, 18-19, 21-22, and 27-28 are presently under examination.
Priority
The instant application is a 35 U.S.C. § 371 International Application PCT/US2022/027119, filed April 29, 2022, which claims the benefit of U.S. Provisional Application No. 63/181,496, filed April 29, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 11/13/2023 and 03/26/2026 are in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
The applicant has an obligation to call the most pertinent prior art to the attention of the U.S. Patent and Trademark Office in a proper fashion. Burying one reference in over eight hundred other IDS references is like citing nothing. PENN YAN BOATS, INC. v. SEA LARK BOATS, INC. 175 USPQ 260 (S.D. Fla. 1972). Golden Valley Microwave Foods, Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (U.S. Dist. N. Dist. IN 1992).
Specification
Acknowledgement is made of the drawings received 10/25/2023.
The drawings are objected to because:
1. FIGs. 1, 4, 5, 7, and 8 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g).
In FIG. 1, the heme structure is blurry and illegible. In FIG. 2, the labels on the x- and y-axes of the Volcano plots are illegible. As recited in 37 CFR 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 16 is objected to because of the following informality: there should be a space inserted between “and” and “12-hydroxyheptadecatrenoic acid” of the claim. Appropriate correction is required.
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 12 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 1 is rejected to as vague and indefinite. It is unclear as to what kind of subject is receiving the method of treating or preventing. Examiner recommends amending the claim to recite “…in a subject in need thereof…” (emphasis added).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation of “all fatty acids present”, and the claim also recites “the EPA and/or E-EPA”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4 is rejected to as vague and indefinite. The word “further” should be amended into the claim since the claimed subject matter of docosahexaenoic acid or derivatives represent an additional element to the composition.
Claim 3 is rejected to as vague and indefinite for the phrase “…of all fatty acids present, docosahexaenoic acid or derivatives thereof…”. Is the Applicant claiming that the fatty acids present are only docosahexaenoic acid or its derivatives thereof, or is the Applicant claiming all three possibilities are present (e.g. any fatty acid, docosahexaenoic acid, or its derivatives thereof)? Appropriate correction is required.
Claim 12 is rejected as vague and indefinite for its usage of the term “chemically distinct”. The specification provides no definition for the phrase “chemically distinct” and the Examiner is not aware of the metes and bounds of what determines “chemically distinct”. Is the methyl ester of EPA chemically distinct, or a deuterated version of EPA? Examiner suggests amending the claim to recite “…further comprises a polyunsaturated fatty acid that is not EPA or E-EPA” if that is what the Applicant intends.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14-16, and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14, which depends on claim 13, recites, “wherein the LCFA is a long chain polyunsaturated fatty acid” (emphasis added). Meanwhile, claim 13 already recites that “the polyunsaturated fatty acid is a long-chain fatty acid”. Therefore, claim 14 does not further limit the claim from which it depends, claim 13.
Claims 15, 16, and 18, which all depend on claim 12, recite the term “derivative” throughout, as in “the polyunsaturated fatty acid or derivative…”. However, claim 12 is drawn specifically to a polyunsaturated fatty acid only and not a derivative. Therefore, claims 15, 16, and 18 broaden the scope of the claim from which they depend.
Claims 15, 16, and 18, which all depend on claim 12, all recite the phrase “…at least one selected from the group of…”, which indicates the possibility of multiple sections. However, claim 12 only recites “a polyunsaturated fatty acid”, which is indicative of only one, and not “at least one of”. Therefore, claims 15, 16, and 18 broaden the scope of the claim from which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Scope of Enablement - Prevention
Claims 1-5, 9-10, 12-16, 18-19, 21-22, and 27-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), first paragraph, because the specification, while being enabling for treating, does not reasonably provide enablement for preventing. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly discussed: (A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The term “prevention” (page 25, para [0083]), is defined:
The term "prevention" in relation to a given disease or disorder means preventing the onset of disease or disorder development if none had occurred; preventing the disease or disorder from occurring in a subject that may be predisposed to the disease or disorder but has not yet been diagnosed as having the disease or disorder; and/or preventing further disease or disorder development if already present.
It is presumed “prevention” of the claimed condition would require a method of identifying those individuals who will develop the claimed condition before they exhibit symptoms. The current state of the art is that that full scope of diseases claimed within instant claims is not preventable or curable.
There is no evidence in the prior art that the instant composition would be usable as a preventative method, particularly for preventing diseases such as cardiovascular disease. “Preventing” connotes an absolute absence of a condition which cannot reasonably be achieved with regard to infections, with few exceptions (such as vaccines to prevent the development of pathogen-borne illnesses). In addition, there is no definitive method by which to determine whether a patient will develop a particular condition and, thus, be in need of preventive therapy. This is distinguished from preventing the relapse or recurrence of certain conditions, in which case an objective basis may exist to identify patients at risk of disease or infection, and could reasonably be construed as treatment. Prior to the initial onset or occurrence, however, even if a patient can be identified as having known risk factors for a condition, there is no certainty that the patient would in fact develop the condition. Further, the failure of a disease, infection, or condition to develop cannot reliably be attributed to the claimed active agent(s). The non-development of a condition such as diseases such as cardiovascular disease may be due to other factors such as lifestyle. In this sense, in the context of preventing a disease, the level of unpredictability is extremely high.
The factors to be considered in making an enablement rejection were summarized above. 1) Preventing diseases requires identifying those patients who will acquire the condition before the symptoms occur. This would require extensive and potentially open-ended clinical research on healthy subjects. 2) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical pharmacology and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will develop cardiovascular disease before the fact. 6) The artisan using Applicants invention would be a Board Certified physician. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of cardiovascular disease. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable for any agent to be able to prevent cardiovascular disease. 7) It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved" and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed conditions.
As claims 2-5, 9-10, 12-16, 18-19, 21-22, and 27-28 depend upon claim 1, they are also rejected.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 9, 19, 21-22, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonutti et al. (US 2019/0105356 A1, published April 11, 2019)(hereinafter, ‘Bonutti’).
Regarding claims 1 and 4: Bonutti discloses (Claims 1-3) a method of treating or preventing venous thrombosis in a subject in need thereof, the method comprising administering to the subject a composition comprising eicosapantaenoic acid (EPA), wherein the composition contains a dose of EPA in the range of 240 mg to 1000 mg, or wherein the subject is administered 1 gram to 2 grams of EPA per day.
Regarding claim 3: Bonutti discloses a composition with 5 to 25% by weight of EPA (reference claim 28).
Regarding claim 9: Bonutti discloses (page 4, para 0034) that “the treatment described herein could be provided short term (i.e. starting preoperatively or pre-hospitalization for one day up to one week) and continued postoperatively or post-hospitalization for two weeks or for as long as three months after surgery…” (emphasis added).
Regarding claims 19, 21-22, and 27-28: The wherein clauses of claims 19, 21-22, and 27-28 do not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: a method treating or preventing venous thrombosis in a subject, the method comprising administering to the subject a pharmaceutical composition comprising EPA and/or E-EPA to provide a daily dose of about 1 g to about 20 g of the EPA and/or E-EPA to the subject. MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case, the entirety of the wherein clauses of claim 18-19, 21-22, and 27-28 appears to be the result of the process made obvious by the prior art: a method treating or preventing venous thrombosis in a subject, the method comprising administering to the subject a pharmaceutical composition comprising EPA and/or E-EPA, e. g. the intended result of a process step positively recited. As such, these limitations in the instantly claimed methods have not been given any weight.
Altogether, each and every element of claims 1, 3-4, 9, 19, 21-22, and 27-28 are taught by Bonutti and thus, the claims are anticipated.
Claim(s) 1-2, 4-5, 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sancilio et al. (US 9,364,558 B2, published June 14, 2016)(hereinafter, ‘Sancilio’).
Regarding claims 1: Sancilio recites a method for the treatment of cardiovascular disease comprising administering to a patient, a pharmaceutical composition comprising “from about 60% (wt/wt)-about 85% (wt/wt) of at least one omega-3 fatty acid ester, selected from the group
consisting of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acids (EPA) ester, (all-Z omega-3)-4,7,10,13,16, 19-docosahexaenoic acids (DHA) ester…” (reference claim 1), wherein “…said cardiovascular disease or condition include…venous thrombosis” (reference claim 35), and wherein “…said composition is administered in amounts providing a daily amount of said at least one omega-3 fatty acid ester of from about 0.5 g to about 10 g” (reference claim 36).
Regarding claims 2, 4-5,10: Sancilio recites (col 9, lines 48-54), “methods are provided for administering at least about 4 g/day or certain embodiments of the compositions described herein comprising ethyl eicosapentaenoic acid (ethyl-EPA), at least one surface active agent and substantially no docosahexaenoic acid (DHA), where the ethyl-EPA constitutes at least about 96% by weight of the total Omega-3 fatty acid esters in the composition” (emphasis added).
Regarding claim 9: Sancilio recites (col 26, lines 44-54) a length of administration, for example “over a period of about 1 to about 200 weeks, about 1 to about 100 weeks, about 1 to about 80 weeks, about 1 to about 50 weeks…”.
Altogether, each and every element of claims 1-2, 4-5, 9-10 are taught by Sancilio and thus, the claims are anticipated.
Claim Rejections - 35 USC § 103
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) 1-2, 4-5, 9-10, 12-16, 18-19, 21-22, and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sancilio et al. (US 9,364,558 B2, published June 14, 2016)(hereinafter, ‘Sancilio’) and Bannenberg et al. (US 10,568,858 B2, published February 25, 2020)(hereinafter, ‘Bannenberg’).
The previous 102 rejection is incorporated herein.
Regarding claims 15-16, and 18: Bannenberg teaches oils that have anti-inflammatory properties (Abstract), exemplified by the polyunsaturated fatty acids (PUFA) EPA and DHA. Additionally, Bannenberg teaches (col 4, lines 3-5) that “increased levels of EPA and DHA are associated with decreased incidence of, and propensity to, develop cardiovascular disease.” In addition to EPA and DHA, Bannenberg enriches oils with at least one SPM (Specialized Proresovling Mediator) or SPM precursor, and that SPMs that may be present include 15-deoxy-delta12,14-prostaglandin J2 (col 9, lines 32) and resolvin D1 (claim 4, col 30, line 17). Bannenberg provides explicit motivation (col 3, lines 40-45) to add these additional SPMs to a PUFA composition:
Of particular relevance to the current invention, some of the monohydroxylated and epoxygenated derivatives constitute biosynthetic intermediates with more potent anti-inflammatory activity than EPA and DHA since they are more proximate intermediates in the biosynthesis of several SPMs than EPA and DHA themselves. (emphasis added)
Here, Bannenberg reveals that these derivatives often have more potent anti-inflammatory activity than EPA and DHA.
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time before the effective filing date of the claimed the invention, to practice the disclosed utility of Sancilio with the claimed compounds and pharmaceutical composition: treating venous thrombosis. One would have motivated to include 15-deoxy-delta12,14-prostaglandin J2 and resolvin D1 because Bannenberg includes these additional elements in their composition, and furthermore, Bannenberg teaches that these derivatives are often more potent against cardiovascular disease than EPA and DHA themselves.
Regarding claims 12-15: Instant claims 12-14 are drawn to a composition further comprising a polyunsaturated fatty acid and not to its ester derivative. Sancilio recites (reference claim 3) a method for the treatment of cardiovascular disease (e.g., venous thrombosis of reference claim 35) comprising administering to a patient, a pharmaceutical composition, wherein “…said composition is a mixture of EPA fatty acid ester and DHA fatty acid ester”.
Acids and ethyl esters are prima facie obvious. In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970), wherein COOH v. COOC2H5 was found prima facie obvious. Reference claim 3 discloses a composition of a mixture of EPA fatty acid ester and DHA fatty acid ester. DHA is, in fact, a long-chain polyunsaturated fatty acid and satisfies the requirement of both instant claims 13 and 14.
Regarding claims 19, 21-22, and 27-28: The claim language around “…administration of the pharmaceutical composition” is language around amounts and concentrations. In this instance, modifying concentrations or quantities (result effective variables) would be obvious based on routine optimization (In re Aller), unless there is evidence to the contrary. The selection of reaction administration conditions is more optimization by more modification of routine experimentation and within one skilled in the art. Change in temperature, concentration, or both is not patentable modification in the absence of unexpected results which is different in kind and not degree. Therefore, the determination of workable administration conditions would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the criticality of the administration conditions, the determination of the optimum or administration conditions given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 U.S.P.Q. 33 (C.C.P.A. 1937). In re Russell, 439 F.2d 1228; 169 U.S.P.Q. 426 (C.C.P.A. 1971). Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."). Accordingly, claims 6 is rejected.
Thus, said claim are obvious and claims 1-2, 4-5, 9-10, 12-16, 18-19, 21-22, and 27-28 are rejected.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 10,940,131 B2 (published 3/9/2021). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 6 is drawn to a method of treating a cardiovascular-related disease in a subject, comprising administering a therapeutically effective amount of a composition comprising EPA (or a derivative thereof), DHA (or a derivative thereof), and at least one surfactant, wherein the cardiovascular-related disease is deep vein thrombosis. The instant claim recites “comprising” and thus opens the claim to the inclusion of additional agents. Furthermore, reference claim 6 recites a method that is more specific than the method of instant claim 1, in that reference claim 6 recites a “species” (“deep vein thrombosis”) of the instantly claimed genus (“venous thrombosis”) and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). See MPEP 804(II)(B)(1) and MPEP 804(II)(B)(2).
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 68 of copending Application No. 18/472,875 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 68 is drawn to a method of treating a disease in a subject, comprising administering a therapeutically effective amount of a composition comprising one or more polyunsaturated fatty acids (PUFAs) and a source of phospholipid, wherein EPA is, in fact, a PUFA. The instant claim recites “comprising” and thus opens the claim to the inclusion of additional agents, such as “a source of phospholipid”. Furthermore, in reference specification, Applicant recites that, in some embodiments, the disease is cardiovascular disease (para 0020), and in some embodiments, the cardiovascular disease is selected from thrombotic disease (para 0020), and finally, a “thrombotic disease” includes (para 0145) “disseminated intravascular coagulation, other diseases involving excessive platelet activation, venous thrombosis, and thrombotic events related to major adverse cardiovascular event” (emphasis added). Therefore, reference claim 68 is drawn to a cardiovascular disease that includes venous thrombosis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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, Jeffrey H Murray can be reached at 571-272-9023. 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.
/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
Prosecution Insights