DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. Claims included in the prosecution are claims 1-13.
Claim Objections
Claims 1, 4-7 and 12 are objected to because of the following informalities: “DAO” should be written out as “diamine oxidase” since the full term should appear prior to the acronym. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the second instance of “treating” in the first line should be removed to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating chronic fatigue, fibromyalgia, and spondylitis, does not reasonably provide enablement for preventing chronic fatigue, fibromyalgia, and spondylitis. 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.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." These factors include, but are not limited to: [AltContent: rect]
(A) The breadth of the claims; [AltContent: rect]
(B) The nature of the invention; [AltContent: rect]
(C) The state of the prior art; [AltContent: rect]
(D) The level of one of ordinary skill; [AltContent: rect]
(E) The level of predictability in the art; [AltContent: rect]
(F) The amount of direction provided by the inventor; [AltContent: rect]
(G) The existence of working examples; and [AltContent: rect]
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to preventing migraine. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites to Cleveland Clinic, which discloses that because experts don’t know the exact cause of fibromyalgia, there’s no known way to prevent it (What causes fibromyalgia?) and you can’t prevent spondylolysis (Can spondylolysis be prevented?). Also, Cedars Sinai discloses that there is no known cure for chronic fatigue syndrome (CFS) (How is chronic fatigue syndrome treated?).
The breadth of the claims
The claims are broadly drawn to preventing migraine, but does not recite how DAO can not only treat chronic fatigue syndrome, fibromyalgia, and spondylitis, but prevent chronic fatigue syndrome, fibromyalgia, and spondylitis as well.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful protocols for carrying out the invention as claimed, other than treating chronic fatigue syndrome, fibromyalgia, and spondylitis. The latter is corroborated by the working examples.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 4, 6-8 and 11 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Missbichler et al (U.S. Patent Application Pub. No. 2008/0193491 published on 08/14/2008) (hereinafter Missbichler).
Missbichler teaches compositions for treating histamine-induced diseases and conditions and reducing histamine from the gastro-intestinal tract comprising diaminooxidase (“DAO”) (also commonly known as amine oxidase, histaminase, or diamine oxidase) (Abstract and para [0001], [0053], and [0054]) wherein the composition is in the form of a functional food, including a food, a food supplement (i.e., a nutritional supplement), or a dietary foodstuff comprising DAO (para [0032], [0053], and [0054]) and a method of treatment comprising administering the functional food (para [0032]) wherein the histamine-induced diseases and conditions include headaches (para [0012]).
Missbichler further teaches the functional food wherein, in an exemplary embodiment, the composition comprises 3% by weight of DAO (claim 20, para [0064]).
Missbichler further teaches the functional food wherein, in exemplary embodiments, the DAO is extracted from animal organisms and is also made recombinantly (i.e., of biotechnological original) (para [0041]-[0047]).
Missbichler further teaches the functional food wherein, in an exemplary embodiment, is in the form of a gastric-juice resistant (i.e., gastrointestinal protected) capsule or pellet (para [0029], [0033], and [0039] and claims 19-21, 31, 35, and 36).
Accordingly, Missbichler anticipates the instant claims insofar as disclosing administering a functional food comprising DAO.
In regards to instant claim 1 reciting treating or preventing chronic fatigue or fibromyalgia, the claim as currently recited does not require the patient to have a chronic fatigue or fibromyalgia (the claim recites preventing chronic fatigue or fibromyalgia and also does not recite treating to a patient in need thereof). Therefore, since the functional food comprising DAO in the prior art is substantially the same as the claimed functional food comprising DAO and is administered to a patient, the functional food comprising DAO of the prior art would necessarily treat or prevent chronic fatigue or fibromyalgia when administered.
As to claim 8, a food composition is necessarily either dairy-based or non-dairy-based and, thus, meets the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
1. Claims 1-8 and 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Missbichler et al (U.S. Patent Application Pub. No. 2008/0193491 published on 08/14/2008) (hereinafter Missbichler) in view of Drent (Bladder pain syndrome/interstitial cystitis, Feb. 2008).
Missbichler teaches compositions for treating histamine-induced diseases and conditions and reducing histamine from the gastro-intestinal tract comprising diaminooxidase (“DAO”) (also commonly known as amine oxidase, histaminase, or diamine oxidase) (Abstract and para [0001], [0053], and [0054]) wherein the composition is in the form of a functional food, including a food, a food supplement (i.e., a nutritional supplement), or a dietary foodstuff comprising DAO (para [0032], [0053], and [0054]) and a method of treatment comprising administering the functional food (para [0032]) wherein the histamine-induced diseases and conditions include headaches (para [0012]).
Missbichler further teaches the functional food wherein, in an exemplary embodiment, the composition comprises 3% by weight of DAO (claim 20, para [0064]).
Missbichler further teaches the functional food wherein, in exemplary embodiments, the DAO is extracted from animal organisms and is also made recombinantly (i.e., of biotechnological original) (para [0041]-[0047]).
Missbichler further teaches the functional food wherein, in an exemplary embodiment, is in the form of a gastric-juice resistant (i.e., gastrointestinal protected) capsule or pellet (para [0029], [0033], and [0039] and claims 19-21, 31, 35, and 36).
Missbichler further teaches the functional food in the form of pellets having an average diameter of from 0.5 to 5 mm, in particular of from 0.7 to 2 mm. Such size has the advantage that the pellets can quickly pass the stomach (para [0036]).
Although Missbichler teaches a method of treating histamine-induced diseases and conditions, Missbichler lacks sufficient specificity for specifically treating patients suffering from chronic fatigue or fibromyalgia.
However, Drent discloses that the process that leads to the development of bladder pain syndrome (BPS) and Interstitial cystitis (IC) (BPS/IC) is triggered by an insult to the urothelium, such as bacterial cystitis, childbirth, or surgery. In people prone to BPS/IC the protective GAG layer disappears and allows leakage and absorption of urinary solutes to occur; the major solute being potassium. Ongoing exposure of the bladder wall to potassium causes inflammation, irritation, and injury. Histamine is released by the mast cells. Histamine activates C-nerve fibers, which release substance P and other neuropeptides that cause further cell damage and mast cell activation (neurogenic inflammation) (Figure 2) (page 47). BPS/IC can be treated with histamine-receptor antagonists such as H2 blockers which inhibit the release of histamine from mast cells (page 49). Many patients with BPS/IC may also have one or more associated disorders such as fibromyalgia and chronic fatigue syndrome (page 50).
Accordingly, it would have been prima facie obvious to one of ordinary skill to specifically treat a patient that is suffering from chronic fatigue or fibromyalgia with the functional food of Missbichler since the functional food reduces histamine as taught by Missbichler, reduction of histamine treats patients with BPS/IC, and patients with BPS/IC often have chronic fatigue syndrome and/or fibromyalgia as taught by Drent.
As to claim 5 reciting between 0.01% and 1% DAO, Missbichler discloses wherein DAO degrades histamine (para. [0018]). Accordingly, it would have taken no more than the relative skill of one of ordinary skill in the art through routine optimization to have arrived at the claimed amount of DAO depending on the amount of histamine needed to be degraded. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05.
As to claim 8, a food composition is necessarily either dairy-based or non-dairy-based and, thus, meets the claim.
As to claim 12, Missbichler discloses wherein the food composition may be in the form of a capsule and wherein a size of 0.5 to 5 mm has the advantage of quickly passing the stomach. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composition as a capsule with a size of 0.5 to 5 mm (i.e. microcapsule) in order to have the capsule passing the stomach quickly as taught by Missbichler et al.
As to claim 13 reciting wherein the administering reduces the blood histamine level in the patient to levels between 2 and 20 µg/0.1L, since reduction of histamine is desirable as taught by Missbichler and Drent, it would have been obvious to one of ordinary skill in the art to have administered the composition of Missbichler to a patient over an effective time period to reduce histamine levels as much as possible. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05.
2. Claims 9 and 10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Missbichler in view of Drent, and further in view of Bodmer et al (“Biogenic amines in foods: histamine and food processing,” Inflammation Research, Vol. 48, Issue 6, pgs. 296-300 (1999)) (hereinafter Bodmer).
Missbichler and Drent teach a functional food composition as applied to claims 1-8 and 11-13 above as set forth, supra.
Although Missbichler teaches a functional food comprising DAO, Missbichler does not specify that the functional food is in the form of any of the specific products recited in claims 9 and 10.
However, Bodmer teaches the toxicity of histamine content in foods and beverages (Abstract) and that DAO provides a detoxification system that, if inefficient, leads to toxic effects because biogenic amines such as histamine are readily absorbed into systemic circulation (page 296, col 2, second full paragraph).
Bodmer further teaches that a particular beverage with a neglectibly low histamine content is fresh grape juice (page 297, col 2, first full paragraph and page 298, col 1, third full paragraph) and milk and dairy products (page 297, col 1, fourth and fifth full paragraph and Table 1) and that foodstuffs (food and beverages) with low levels of histamine increases food quality and allow individuals at risk a more diversified nutrition (page 299, col 1, last paragraph to page 230, col 1, last paragraph).
As to claim 10, it would have been prima facie obvious to one of ordinary skill to modify the functional food of Missbichler by specifically using fresh grape juice as the specific foodstuff as taught by Bodmer because Missbichler teaches an embodiment where the functional food composition comprising DAO are used in dietary foodstuffs for reducing histamine and treating histamine induced diseases and disorders and Bodmer teaches that fresh grape juice is particularly useful to facilitate DAO detoxify biogenic amines such as histamine as a dietary foodstuff because it has a neglectibly low histamine content, which provides an added benefit of increasing food quality and allowing individuals at risk a more diversified nutrition.
As to claim 9, it would have been prima facie obvious to one of ordinary skill in to modify the functional food of Missbichler by specifically using milk or other dairy products as the specific foodstuff as taught by Bodmer because Missbichler teaches an embodiment where the functional food composition comprising DAO are used in dietary foodstuffs for reducing histamine and treating histamine induced diseases and disorders and Bodmer teaches milk or other dairy products are particularly useful to facilitate DAO detoxify biogenic amines such as histamine as a dietary foodstuff because it has a neglectibly low histamine content, which provides an added benefit of increasing food quality and allowing individuals at risk a more diversified nutrition.
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.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,201,676. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional limitations, such as symptoms) and thus read on the instant claims.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-13 of copending Application No 18/954,396 in view of Missbichler et al (U.S. Patent Application Pub. No. 2008/0193491 published on 08/14/2008) (hereinafter Missbichler) and Drent (Bladder pain syndrome/interstitial cystitis, Feb. 2008).
Although the claims at issue are not identical, they are not patentably distinct from each other because both recite a method of administering a composition comprising DAO. The pending claims differ in reciting treating chronic fatigue or fibromyalgia.
It would have been prima facie obvious to one of ordinary skill in the art to specifically treat a patient that is suffering from chronic fatigue or fibromyalgia because Missbichler teaches wherein DAO treats histamine diseases/disorders, Drent teaches that reduction of histamine treats patients with BPS/IC, and most patients with BPS/IC have chronic fatigue syndrome and/or fibromyalgia.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-13 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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