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 Claims
Claims 1, 3, 10 – 12, 17 – 19, 23, 28 – 31, 33, 36 – 37, 40, 42 – 43, 54, 61 and 89 – 93 are pending and rejected.
Election/Restrictions
Applicant election, without traverse, of Compound X in the reply filed on June 25, 2026 is acknowledged. Compound X is presented below:
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Examination: Applicant’s elected species, Compound X, is not allowable over the prior art.
Priority
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Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 26, 2024 and June 25, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The specification amendment filed on November 13, 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. Specifically, the following new phrase is not supported by the application (as filed on November 13, 2023): “The specifications of each of the foregoing applications are hereby incorporated by reference in their entirety”. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. See MPEP 211.02 and MPEP 201.06(c)(IV). PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to 371 applications. When a benefit claim is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. This objection may be overcome by deleting the phrase “The specifications of each of the foregoing applications are hereby incorporated by reference in their entirety”.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 10 – 12, 17 – 19, 23, 28 – 31, 33, 36 – 37, 40, 42 – 43, 54, 61 and 89 – 93 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 recites the limitation:
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See, e.g., page 2, lines 12-13. Claim 1 further recites the moieties a), e) and f):
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. See, e.g., page 3, lines 1-2. According to the limitation “having one or two additional N-atoms” above,
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must contain one or two N-atoms in addition to the nitrogen atom connected to the carbonyl moiety (-C(=O)-) in Formula XI. However, the moieties a), e) and f) do not feature additional one or two N-atoms in the aromatic or partially aromatic bicyclic amine ring system. Thus, the metes and bounds are indefinite. Dependent claims 3, 10 – 12, 17 – 19, 23, 28 – 31, 33, 36 – 37, 40, 42 – 43, 54, 61 and 89 – 93 do not address or remedy the deficiencies in claim 1 and are also considered indefinite.
In order to overcome the rejection, Applicant may amend the limitation as follows:
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is an aromatic or partially aromatic bicyclic amine
Claim 29 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
The claim recites the limitations “(e.g., 50%, 55%, 60%, 65%, 70%, 80%, 85%, 90%, 95%, or at least 100%)” and “(e.g., 10%, 15%, 20%, 25%, and 30%). The term “e.g.” is interpreted as “for example” and renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
In order to overcome the rejection, Applicant may delete the exemplary language limitations from the claim.
Claim 90 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
The claim contains the trademark/trade name Scenesse ®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe afamelanotide and, accordingly, the identification/description is indefinite.
In order to overcome the rejection, Applicant may delete the trademark/trade name Scenesse ® from the claim.
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.
Claims 1, 3, 10 – 12, 17 – 19, 23, 28 – 31, 33, 40, 42 – 43 and 91 – 93 are rejected under 35 U.S.C. 103 as being unpatentable over Halloy et al., Cell Chemical Biology (2021), vol. 28, pages 1-14 (Epub 22 March 2021), DOI: 10.1016/j.chembiol.202.02.021 in view of Alberati et al. WO 2015/165842 A1, both cited in IDS dated September 26, 2024.
Determining the scope and contents of the prior art
Halloy et al. teach “[e]rythropoietic protoporphyria is a rare disease caused by lack of ferrochelatase… [p]atients accumulate protoporphyrin IX in their circulation”. See, e.g., page 1, In brief. Halloy el al. shows a graphical abstract of Erythropoietic protoporphyria and Glycine transporter inhibitor show below:
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. See, e.g., page 1.
Halloy further teaches administering low micromolar concentrations of bitopertin (GlyT1, glycine transporter 1 inhibitor) markedly decreased levels of Protoporphyrin IX (PPIX) in the treatment of K56211B4 cells. Similar effects are observed in erythroid cells cultured and differentiated ex vivo from an EPP ( patient. See, e.g., pg. 1222, bridging paragraph between left and right columns. The structure of bitopertin is presented below:
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. See, e.g., pg. 1226, page 1 and Figure 3G.
Ascertaining the differences between the prior art and the claims at issue
Compared to claim 1 and Applicant’s elected species, Halloy et al. do not teach administering the pharmaceutical composition comprising instant Compound X:
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Rationale for a prima facie case of obviousness
Alberati et al. teach GlyT1 inhibitors of formula II:
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. See, e.g., page 2, lines 16-17. Alberati specifically teaches compound,
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. The compound is used as GlyT1 inhibitor in the method for the treatment of hematological disorders. See, e.g., page 6, lines 7-14. Alberati further teaches said compound can be combined with pharmaceutically inert, inorganic, or organic excipients for the production of a pharmaceutical preparations. See, e.g., page 10, lines 13-24.
According to MPEP §2141(III), two of the rationales in the KSR decision states “(C) Use of known technique to improve similar devices (methods, or products) in the same way;… (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention”. KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Halloy teaches administering the pharmaceutical composition comprising bitopertin,
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, markedly decreased levels of Protoporphyrin IX (PPIX) in the treatment of K56211B4 cells and erythroid cells cultured and differentiated ex vivo from an EPP (a type of hematological disorder) patient. Alberati teaches administering the compound
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as GlyT1 inhibitor in the method for the treatment of hematological disorders. A person of ordinary skill in the art would have been motivated to prepare and administer a pharmaceutical composition comprising
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because Halloy teaches structurally the same compound, bitopertin can be formulated and used to treat erythropoietic protoporphyria in a patient, while preserving its pharmaceutical properties. The PHOSITA would have had a reasonable expectation of preparing the composition comprising [5-methanesulfonyl-2-((S)-2,2,2-trifluoro-l- methyl-ethoxy)-phenyl]-(3-trifluoromethyl-5,7-dihydro-pyrrolo[3,4-b ]pyridin-6-yl)-methanone because similar properties would have been expected from structurally similar compounds.
With respect to claims 3, 10 – 12, 17 – 19, 23, 28 – 31, 33, 36 – 37, 40, 42 – 43, 54, 61 and 89 – 93, according to the graphical abstract of Erythropoietic protoporphyria and Glycine transporter inhibitor in Halloy et al., treating erythropoietic protoporphyria in a patient comprising administering the pharmaceutical composition comprising said compound (GlyT1 inhibitor) would initiate a cascade network of downstream reactions including inhibition of accumulation of protoporphyrin IX (PPIX), decreasing oxidative damage markers and decreasing cellular photosensitivity in patients. MPEP §2112.01(I)-(II) states:
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)… Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
Since Halloy et al. teach similar method and Alberati et al. teach identical Compound X as claimed in the instant claims, the method and compound would inherently also possess the same photosensitive and PPIX levels properties of treating erythropoietic protoporphyria in the patients. Thus, the combined teachings of the prior art would have rendered the instant claim prima facie obvious.
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, 3, 10 – 12, 17 – 19, 23, 28 – 31, 33, 36 – 37, 40, 42 – 43, 54, 61 and 89 – 93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97 – 99 of copending Application No. 19/077,940 (US ‘940). Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 97 in US ‘940 claims a method:
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Claim 99 specifically claims Compound X:
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. See, e.g., page 12, 1st column, 3rd compound.
The claims in US ‘940 do not specifically claim a method of treating erythropoietic protophyria (EPP) or X-linked protoporphyria in a subject.
MPEP §804(II)(B)(1)(2nd paragraph) states:
“Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).”
For example, the specification of US ‘940 teaches the same compound is used to treat erythropoietic protophyria (EPP) or X-linked protoporphyria in a subject. See, e.g., page 1, lines 19-23.
MPEP §2112.01(I)-(II) states:
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)… Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”
Since the claims in US ‘940 claim similar method and identical Compound X as claimed in the instant claims, the method and compound would inherently also possess the same photosensitive and PPIX levels properties of treating erythropoietic protoporphyria in the patients. Thus, the claims in US ‘940 render the instant claims unpatentable for anticipatory-type double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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