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 .
Priority
The instant application is a 371 National Stage Entry of PCT/FI2022/050872 filed on December 27, 2022 which claims priority to foreign application No. FI20216361 filed on December 29, 2021.
Status of Claims
Acknowledgement is made of original (1), amended (2-10) claims filed on July 1, 2024. Claims 1-10 are pending in instant application.
Information Disclosure Statement
The information disclosure statement filed on February 27, 2025 has been considered.
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 1-10 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.
Regarding claims 1-10, independent claim 1 begins “An acetaldehyde-binding preparation for use”, which indicates a composition product with an intended use, but then goes on to recite method steps. The instant specification also indicates “preparation” is reference to a composition, not a method (see instant spec. at p. 14 ¶[0051]). It is unclear if the claims are meant to be composition claims or method claims, and if composition claims, it is unclear what the claimed composition comprises. Claim 1 indicates the preparation is “characterized by administering 50-500 mg of L-cysteine”, which also appears to be a step (“administering”). In light of the specification, for the purposes of applying art claim 1 is interpreted as a composition that comprises 50-500 mg of L-cysteine. The dependent claims do not clarify if the claims are meant to be composition or method claims, and are thus included in instant rejection.
Claims 2-4 reference intended method steps and do not appear to structurally limit the composition.
Claim 5 appears to reference narrowed dose ranges of L-cysteine in a composition, or three separate compositions, or even an intended dose regimen for a method.
Claims 6-7 appear to further indicate the composition further comprises a pharmaceutical acceptable carrier.
Claims 8-9 appear to be functional limitations of the composition without reciting additional structure. See MPEP § 2173.05(g).
Claim 10 appears to recite further intended use.
For the purposes of applying art:
the limitations of claims 1, 2-4, 5, 10 are met by the structural limitations of a composition comprising 50-500 mg of L-cysteine,
the limitations of claim 6 are met by a composition comprising 50-500 mg L-cysteine and a pharmaceutical carrier,
the limitations of claim 7 are met by a composition comprising 50-500 mg L-cysteine and a pharmaceutical carrier selected from the list,
the limitations of claim 8 are met by a composition comprising 50-500 mg of L-cysteine, wherein the composition is formulated as a capsule, and the capsule, when administered to a subject, is capable of releasing the L-cysteine into the stomach of said subject for 0.5 to 8 h,
the limitations of claim 9 are met by a composition comprising 50-500 mg of L-cysteine, and the composition, when administered to a subject, is capable of releasing the L-cysteine into the stomach of said subject as 40-80 mg in one hour.
Further regarding claim 3, the phrases “(stimulated)” and “(fast)” in parentheses are unclear if they are simply defining the prior terms or further limiting. The Examiner suggests amending to remove the parentheses phrases since for “G-17S”, “s” is known in the art to refer to stimulated, and “G-17B”, “b” is known in the art to refer to basal.
Further regarding claim 5, the phrases "preferred", “more preferably”, and “most suitably” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-7, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014/184435 A1 to Suovaniemi et. al.1
Regarding claims 1-5, 10, and a composition comprising 50-500 mg of L-cysteine and intended use, Suovaniemi teaches a composition comprising 50-500 mg of a cysteine such as L-cysteine (see Suovaniemi claims 1, 6). Suovaniemi also teaches a composition formulated as a capsule comprising 100 mg L-cysteine, 50 mg Eudragit RS-PO, 40 mg of calcium hydrogen phosphate, and 8 mg of titanium dioxide (see Suovaniemi at p. 15 lines 13-15). Suovaniemi teaches administering this composition to patients previously screened with a GastroPanel® in an attempt to treat severe atrophic gastritis of the gastric corpus over 3 months (see Suovaniemi at p. 15). Suovaniemi teaches measures to reduce the risk of developing gastric cancer include screening such as with a GastroPanel® test (see Suovaniemi at p. 10 line 13), which also aids in distinguishing patients who suffer from H. pylori-related gastritis and subjects who suffer from only chronic atrophic gastritis (see Suovaniemi at p. 14 line 1).
Regarding instant claims 6-7 and a carrier, Souvaniemi teaches an additional carrier selected from chitosans, alginates, aluminum hydroxide, sodium carboxymethyl cellulose, sodium hydrogen (see Suovaniemi claim 7), reading on the instantly claimed carriers.
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.
Claim(s) 8-9are rejected under 35 U.S.C. 103 as being unpatentable over Suovaniemi as applied to claims 1-7, 10 above.
Regarding instant claim 8 and a capsule with slow-release of L-cysteine, Suovaniemi teaches the composition with a releasing speed of 30 – 120 minutes (see Suovaniemi claim 4), encompassed by the instant range of 0.5 to 8 h (see MPEP § 2144.05(I)). Suovaniemi teaches the composition may be formulated as a capsule (see Suovaniemi claim 11).
Regarding instant claim 9 and slow-release L-cysteine, Suovaniemi teaches the composition is capable of maintaining an effective concentration in the stomach for at least 30 minutes (see Suovaniemi claim 3).
The prior art differs from the instant claims as follows: While Suovaniemi teaches a composition maintaining an effective concentration in the stomach for at least 30 minutes, Suovaniemi does not specify the amount releases in an hour.
However,
The slow-release rate of L-cysteine is a result-effective variable recognized by the prior art. Suovaniemi teaches the carrier will facilitate controlled, sustained release of the active agent (see Suovaniemi at p. 5 lines 30-31), in an initial dose of 50-500 mg (see Suovaniemi at p. 6 line 17) and released during a period of 60-120 minutes (see Suovaniemi at p. 6 lines 6-8). Souvaniemi also teaches the instantly claimed carriers (see Souvaniemi claim 6). Souvaniemi thus recognizes that the initial formulation of L-cysteine must be tailored to result in the ideal amount of L-cysteine released in vivo.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.05(II), a prima facie case of obviousness exists for optimization within prior art conditions or through routine experimentation. The prior art teaches the structural limitations of the instant claims, and recognizes slow-release formulations to be a result-effective variable. Accordingly, an artisan would readily appreciate that the formulation could be optimized to release 40-80 mg of L-cysteine in the stomach in an hour in order to have a therapeutic benefit.
Furthermore, it is well-within the ordinary skill in art to optimize a known composition for the same purpose as taught by the prior art.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
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 1-10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 8,758,812 B22 in view of Lenz et. al.3 Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-5, 10, and a composition comprising 50-500 mg of L-cysteine and intended use, US’812 claims a slow-release composition comprising an acetaldehyde-binding compound (US’812 claims 1-12, 16-17, 22-31) such as L-cysteine (US’812 claim 18-19), which may be present in 1-500 mg (US’812 claim 13).
Regarding instant claims 6 and a carrier, US’812 claims wherein the composition further comprising a polymer that does not dissolve in the stomach and forms a matrix, allowing the compound to diffuse in a sustained manner in the stomach (US’812 claim 5) which is understood to read on the instant “carrier, which controls the releasing speed of the L-cysteine”.
Regarding instant claim 8 and a capsule with slow-release of L-cysteine, US’812 claims wherein the composition is a capsule (US’812 claims 14-15). US’812 claims wherein the compound is released in the stomach for at least 30 min (US’812 claim 20), or within the instant range of 0.5 – 8 h (US’812 claim 21).
The patented claims differ from the instant claims as follows: US’812 does not specifically claim the carriers listed in instant claim 7, or wherein the amount of compound released in the stomach is 40-80 mg in one hour as in instant claim 9, nor an intended use.
However,
Regarding instant claim 1 and intended use, US’812 claims the composition binds acetaldehyde in the whole length of the intestinal track (US’812 claim 1), and indicates oral administration with the formulation of tablets and capsules (US’812). An artisan would readily appreciate that a composition with overlapping structural limitations intended for the same administration route and formulated to expose the active ingredient throughout the gastroinstestinal tract is capable of performing the instantly claimed intended use of preventing or improving atrophic gastritis.
Regarding instant claim 7 and a carrier, US’812 claims the composition comprises the cellulose derivative hydroxypropyl methylcellulose (US’812 claim 11), which is structurally similar to instantly claimed cellulose derivative sodium carboxymethyl cellulose. Lenz teaches both are known in the art as submucosal fluid cushions for gastrointestinal procedures (see Lenz at Abstract) because they have high viscosities, are non-toxic, and compatible with in vivo applications (see Lenz at p. 186 right col.).
Regarding instant claim 9 and slow-release L-cysteine, the slow-release rate of L-cysteine is a result-effective variable recognized by the patent. US’812 claims the carrier will facilitate sustained release of the active agent (US’812 claims 1, 5), in an initial dose of 1-500 mg (US’812 claim 13) and released during a period of 0.5 – 8 h (US’812 claim 21). US’812 thus recognizes that the initial formulation of L-cysteine must be tailored to result in the ideal amount of L-cysteine release in vivo.
Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior patent for at least the following reason(s):
Regarding carriers, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to one skilled in the art to substitute one known cellulose derivative carrier (e.g. HMPC as claimed by US’812) for another (e.g. instant CMC) because they are known in the art to be compatible with gastrointestinal applications and to possess similar properties (as taught by Lenz).
Regarding slow release, per MPEP § 2144.05(II), a prima facie case of obviousness exists for optimization within prior art conditions or through routine experimentation. The patent teaches the structural limitations of the instant claims, and recognizes slow-release formulations to be a result-effective variable. Accordingly, an artisan would readily appreciate that the formulation could be optimized to release 40-80 mg of L-cysteine in the stomach in an hour in order to have a therapeutic benefit.
Furthermore, it is well-within the ordinary skill in art to:
incorporate one suitable carrier in lieu of another
to optimize a known composition for the same purpose as taught by the prior art.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Conclusion
Claims 1-10 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Cite No. 2 in the IDS filed February 27, 2025. Published November 20, 2014. Hereinafter Suovaniemi.
2 Published June 24, 2014. Hereinafter US’812.
3 Lenz et. al. "COMPARATIVE RESULTS OF GASTRIC SUBMUCOSAL INJECTION WITH HYDROXYPROPYL METHYLCELLULOSE, CARBOXYMETHYLCELLULOSE AND NORMAL SALINE SOLUTION IN A PORCINE MODE" Arq Gastroentero 2010, 47, 2, 184-187. DOI: 10.1590/S0004-28032010000200013. Hereinafter Lenz.
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