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 the Application
The claims of 21 September 2023 are entered.
Claims 1-20 are pending and are being examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/383,130 and 63/376,591, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In the ‘591 application there is no disclosed collagen source as required in claims 1, 12, and 18 of the instant application. In the ‘130 application, there is no discussion of gamma glutamyltransferase levels as required in claims 1, 12, and 18 of the instant application.
The earliest effective filing date of the claimed invention is therefore 10 November 2022, the filing date of the 63/457,9191 application.
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 1-20 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 a method for reducing gamma-glutamyltransferase levels in a subject comprising administering to the subject a glutathione support composition comprising 52 wt% of a collagen source, 32 wt% of L-glutamine, 16 wt% L-cysteine, 0.01 wt% selenomethionine, and 0.03 wt% of a boron salt, where wt% is based on the total weight of the composition, does not reasonably provide enablement for a method for reducing gamma-glutamyltransferase levels in a subject comprising administering to the subject a glutathione support composition comprising the generic mixtures of claims 1, 12 and 18. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredict-ability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention
The invention is drawn to a method of reducing gamma-glutamyltransferase (GGT) levels in a subject by administering a composition comprising a glutathione support composition. The composition contains a collagen source, a glutamate source, a cysteine source, a selenium source, and a boron source.
Breadth of the Claims
The claims range from very broad as in claim 1 to less broad as in claims 12 and 18. The broadest claims as in claims 1-11 recite very broad mixtures of any collagen source, any glutamate source, any cysteine source, any selenium source, and any boron source. Within these claims certain dependent claims narrow the total dose or one aspect of the composition.
Claims 12-17 narrow the overall composition as compared to claims 1-11 by more narrowly defining the percentages of each generic element in the composition.
Claims 18-20 do offer the narrowest composition but still claims the individual components in a mixture of more specific elements, i.e. the L-cysteine, but more broadly for others, i.e. the collagen source options, the glutamate source, the selenium source, and the boron source.
State of the Prior Art
The prior art recognizes glutathione support compositions such as those found in US2012/0029082 A1 which disclose a glutamate source, a cysteine source, and a selenium source. The ‘082 application does not include a collagen source nor a boron source. While these can be found in the prior art separately, there is no explicit rationale that one of ordinary skill in the art would find to add to the ‘082 composition and then apply that composition to a method of reducing GGT levels.
Relative Skill of those in the Art
The relative skill of those in the art is high.
Predictability or Unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
Amount of Direction or Guidance Given
The specification links glutathione levels to liver oxidative stress and elevated GGT, which can be treated with a glutathione support composition as disclosed.
The specification also offers guidance on a wide variety of glutathione support compositions largely reflecting the generic nature and breadth of claims 1, 12,and 18.
Presence/Absence of Working Examples
The Examples suggest three glutathione support compositions that are generically disclosed by dosage and weight percentage for the components without indicating in Table 1 what are the actual collagen source, glutamate source, cysteine source, selenium source, and boron source. Rather each is generically disclosed and p.64-66 offer a mixture of compositions. These compositions are disclosed but not shown to have any impact on GGT levels.
Example 2 shows a single composition A-1 containing 1299 mg marine collagen peptides, 800 mg L-glutamine, 400 mg L-cysteine, 0.01 mg selenomethionine, and 0.75 mg boron salt as reducing GGT levels in four patients. No other compositions from the broad options claimed are demonstrated to reduce GGT levels.
Quantity of Experimentation Necessary
The claims largely set forth broad compositions, particularly for claim 1. These allow for myriad combinations of elements in varying amounts that would still read upon the base formulation. Claim 12 offers ranges of the collagen source, glutamate source, and cysteine source while still allowing each individual component to be broadly claimed. For instance, the collagen source can take the form of any protein or peptide as long as it has at least 5% proline, at least 5% hydroxyproline, and at least 20% glycine residues. Claim 18 most narrowly defines the composition by requiring a specific collagen source and L-cystine, but leaves the other components more broadly claimed. The ranges of each component can also vary significantly.
The skilled artisan is presented not only with the need to prepare wide numbers of compositions to read upon each of claims 1, 12, or 18, but also then test each composition to reasonably ensure that the genus results in GGT reduction when administered. Merely having to produce the compositions might take the form of normal experimentation, but the claims require a structure-function nexus. The art does not recognize compositions as claimed for GGT reduction. The only example shows a single composition resulted in GGT reduction in four patients. This does not reasonably extend to all of the members of the broad genus, as there is no assurance that the effects extend to any combination of a collagen source, a glutamate source, a cysteine source, a selenium source, and a boron source. The effort is placed on the skilled artisan to ensure that the genus has a structure-function correlation that ensures GGT reduction across the genus. Such an effort left only on the part of the skilled artisan constitutes an undue burden, even if the assay for determining GGT is disclosed.
In view of the Wands factors as discussed above, it is the Examiner’s opinion that the claims are not fully enabled and one of skill in the art would have to engage in undue experimentation to practice the invention as claimed herein, without a reasonable assurance of success.
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 6, 9, 10, and 15 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.
With respect to claims 6 and 15, the indefinite language is “hydrolysates thereof (peptides thereof)”. The language is indefinite because it is not clear given the “(peptides thereof)” whether the claim is directed to hydrolysates or whether the peptides thereof are a subset of hydrolysates.
With respect to claim 9, the indefinite language is “catalytically effective amount”. The language is indefinite because it is not clear what sort of catalysis is relevant to set the effective amount.
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 10 recites the broad recitation “(or other flavonoid antioxidants)”, and the claim also recites “kaempferol” 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.
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.
1. Claims 1, 3, 4, and 6-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 8, 10, 11-13, 15, 18, and 19 of copending Application No. 18/370,919 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘919 application claims an overlapping composition and discloses an identical use.
The ’919 application claims a glutathione composition comprising a collagen source matching that instantly claimed, a glutamate source, a cysteine source, and a selenium source (see e.g. claims 1 and 13). The ‘919 application further claims a boron source (see e.g. claims 2 and 15). The collagen can be hydrolyzed marine ovine collagen, hydrolyzed marine or ovine gelatin, hydrolyzed elastin, or a mixture thereof (see e.g. claim 20). The ‘919 application does not claim a method for reducing GGT levels in a subject by administering this composition.
However, the Federal Circuit has found that lack of an explicit claim to a method of use does not preclude a double patenting rejection if an identical use to an identical composition is disclosed in the reference patent:
A claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use (Sun Pharmaceutical. Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010)).
In this instance, the ‘919 application discloses administration of glutathione support composition A-1 containing 1299 mg marine collagen peptides, 800 mg L-glutamine, 400 mg L-cysteine, 0.01 mg selenomethionine, and 0.75 mg boron salt as reducing GGT in subjects when administered (see e.g. Tables 2 and 3). This overlaps with instant claims 1, 12, and 18.
With respect to claims 3, 13, and 20 the ‘919 application also claims that administration can be for at least three days of daily dosage (see e.g. claim 19).
With respect to claims 4 and 14, the ‘919 application claims GSH:GSSH ratio of at least 5:1 after dosing (see e.g. claim 19).
With respect to claims 6, 15, and 16, ‘919 claims the same collagen sources (see e.g. claim 8).
With respect to claim 7 and 19, ‘919 claims the same glutamate sources (see e.g. claim 11).
With respect to claim 8, ‘919 claims the same cysteine sources (see e.g. claim 10).
With respect to claim 8, ‘919 claims selenomethionine (see e.g. claim 12).
With respect to claim 10, ‘919 claims the same active ingredients (see e.g. claim 4).
With respect to claim 11, as noted above ‘919 claims a number of overlapping additional ingredients including taurine and melatonin (see e.g. claim 4).
With respect to claim 17, ‘919 claims marine collagen (see e.g. claim 18).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-8 and 12-120 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-15, and 17 of copending Application No. 18/370,931 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘931 application claims a method that inherently achieves the same results as claimed.
The ’931 application claims a method for treating TB or MRSA in a subject by administering to a patient a composition comprising a collagen source matching the parameters instantly claimed, a glutamate source, a cysteine source, a selenium source, and a boron source (see e.g. claims 1, 10, and 17).
The ‘931 application does not explicitly claim a method of reducing GGT levels through administration of the same composition. However, per MPEP 2112.02 II.,
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
In this instance, the ‘931 application claims administration of the same structure. The method of reducing GGT levels is a new use of the old structure. However, since the ‘931 application claims the same composition and its administration and the instant use is directed to a property of the composition, claim 1 is anticipated.
With respect to claim 2, ‘931 claims an overlapping composition, administration, and dosing of between 1-5 g (see e.g. claims 2 and 7).
With respect to claim 3, as noted above ‘931 claims administration daily for at least 3 days.
With respect to claim 4, the ratio of GSH:GSSH is inherent to the administration. Furthermore, the above co-pending ‘919 application demonstrates that overlapping compositions result in the same change in GSH:GSSH.
With respect to claim 5, ‘931 claims overlapping amounts within the dose (see e.g. claim 7).
With respect to claim 6, ‘931 claims the same collagen source (see e.g. claim 8).
With respect to claim 7, ‘931 claims the same glutamate source (see e.g. claims 10 and 15).
With respect to claim 8, ‘931 claims the same cysteine source (see e.g. claim 9).
With respect to claims 12, ‘931 claims administration with overlapping weight percentages of the ingredients (see e.g. claim 10).
With respect to claim 13, ‘931 claims administration daily for at least 3 days (see e.g. claim 11).
With respect to claim 14, as noted above ‘931 inherently discloses this property, which is supported by the co-pending ‘919 application.
With respect to claims 15-17, ‘931 claims the same collagen sources (see e.g. claims 12-14).
With respect to claim 18, ‘931 claims administration of an overlapping composition (see e.g. claim 17).
With respect to claim 19, ‘931 claims the same glutamine sources (see e.g. claim 20).
With respect to claim 20, as noted above ‘931 inherently discloses this property, which is supported by the co-pending ‘919 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/370,941 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘941 application claims administration of an overlapping composition that inherently achieves the same claimed effects.
The ’941 application claims a method for improving vaccine therapy by administering to a subject a glutathione support composition comprising a collagen source matching the features of the instant claims, a glutamate source, a cysteine source, a selenium source, and a boron source (see e.g. claim 1).
The ‘941 application does not explicitly claim a method of reducing GGT levels through administration of the same composition. However, per MPEP 2112.02 II.,
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
In this instance, the ‘941 application claims administration of the same structure. The method of reducing GGT levels is a new use of the old structure. However, since the ‘941 application claims the same composition and its administration and the instant use is directed to a property of the composition, claim 1 is anticipated.
With respect to claim 2, ‘941 claims dose ranges that add up to within 1-5 g (see e.g. claim 5).
With respect to claim 3, ‘941 claims dosing daily for at least 3 days (see e.g. claims 2-4).
With respect to claim 4, as noted above the alteration of GSH:GSSH is an inherent feature of the composition and supported by the co-pending ‘919 application showing the effects with the same composition.
With respect to claim 5, as noted above ‘941 claims the same dosage.
With respect to claim 6, ‘941 claims the same collagen sources (see e.g. claim 6).
With respect to claim 7, ‘941 claims the same glutamate source (see e.g. claim 7).
With respect to claim 8, ‘941 claims the same cysteine source (see e.g. claim 8).
With respect to claim 9, ‘941 claims selenomethionine (see e.g. claim 9).
With respect to claims 10 and 11, ‘941 claims overlapping secondary ingredients (see e.g. claim 10).
With respect to claim 12, ‘941 claims administration of a glutathione support composition with the same weight percent for each ingredient (see e.g. claim 11).
With respect to claim 13, ‘941 claims dosing for at least three days (see e.g. claims 12-14).
With respect to claim 14, as noted above the GSH:GSSH alteration is an inherent property of administering the composition.
With respect to claims 15-17, ‘941 claims the same collagen sources (see e.g. claims 15-17).
With respect to claim 18, ‘941 claims administration of an overlapping glutathione support composition, including where the collagen is one of the same options (See e.g. claims 11, 15, and 17).
With respect to claim 19, the ‘941 application does not explicitly claim the same composition where the glutamate source is one of the claimed options. However, the ‘941 application claims elsewhere that in a genus of glutathione support compositions that the glutamate source overlaps with that claimed (see e.g. claims 1 and 7), which would be an obvious choice for one of ordinary skill to make since claim 11 already requires a glutamate source.
With respect to claim 20, as noted above the alteration to GSH:GSSH is an inherent property of administration of an overlapping composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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