Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Previous Nonfinal office action mailed October 2, 2025 is withdrawn in view of the incorrect status of the rejection which should have been a final rejection. The same copy of the previous nonfinal is mailed now as a final office action. Applicant Representative Lisa Fazzino discussed during an interview on November 12, 2025 that the office action mailed October 2, 2025 indicated both the status of nonfinal and final. Examiner indicated that the office action should have been a final office action and the office action will be sent as a final office action. App Rep also indicated that the office action on page 7 refers to the term SEQ ID NO:36. Examiner indicated that it was an inadvertent typographical error and will be corrected.
The previous notice of non-responsive amendment mailed April 10, 2025 is withdrawn and vacated in view of arguments filed June 10, 2025.
Claims 109-127, 129-132 are pending. Claims 1-108, 128 are canceled. Claims 109-126 and 129-130 are withdrawn. Claims 127, 131-132 are examined.
Terminal Disclaimer
The terminal disclaimer filed on December 31, 2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 18/304,801, US 11,673,938, US 10,126,313 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
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 127, 131-132 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.
Claims recite “increased conformational stability in a particular conformation compared to its parent GPCR in the same particular conformation” which is confusing and ambiguous because the metes and bounds of the term is not clear. It is not clear how a GPCR mutant which has a different structure from parent GPCR can have the “same particular conformation”. The state of the art is such that one skilled in the art is aware that conformation is affected by structure and different structure would not be in the same particular conformation.
Applicants argue that a person of ordinary skill in the art would understand two variants of a particular GPCR protein can have the same overall tertiary structure and conformational shape but a variant can have mutations that further stabilize the shared tertiary structure. However, the claims encompass large number of genus while applicants discuss specifics of a particular species of receptor to which the claims are not limited. Furthermore, without further limitation of the boundaries of the term, one skilled in the art would know the metes and bounds of a particular conformation.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 127, 131-132 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims encompass the structural and functional terms generically “GPCR”, “adenosine receptor”, conformational stability”, “particular conformation”, and “parent GPCR” which encompasses a large number structures and changes to the specific structure. The genus of GPCR as claimed includes variations in the entire polypeptide. The specification discloses the specific SEQ ID NO: and mutations at specific regions. However, the specification does not disclose the structure of the GPCR variants which would affect the functional limitations desired. Thus, applicant was not in possession of the broad genus of GPCR as claimed.
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d. Additionally, “a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.” Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004).
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004). ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)(Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.).
The specification discloses specific SEQ ID NO: with specific mutational changes. However, the specification does not provide sufficient written description as to the structural features of the claimed genus of GPCRs and the correlation between the structure variant and function of the genus of variants, such as structural region that are essential for GPCR function. The specification does not disclose which mutations are correlated with species with a specific structure. Claims encompass a single mutation to the large number of mutations and limited by functional limitations.
It has been well known that minor structural differences even among structurally related compounds can result in substantially different biology, expression and activities. Based on the instant disclosure one of skill in the art would not know which structural regions are essential, which residues are non-essential and what particular sequence lengths identify essential sequences for identifying a GPCR encompassed by the claimed specificity. Mere idea of function is insufficient for written description; isolation and characterization at a minimum are required.
Schaub et al. (Eur. J. Immunol., 2001) teach that the skilled artisan is well aware that assigning functional activities for any particular GPCR does not provide structure or structural regions for the functional limitations. Even in situations where there is some confidence of a similar overall structure between inhibitors, only experimental research can confirm the artisan’s best guess as to function of the structurally related inhibitors.
For inventions in an unpredictable art, adequate written description of a genus, which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, first paragraph.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddles v.Baird, 30 USPQ2d 1481, 1483. In Fiddles v. Baird, claims directed to mammalian FGF’s were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
Therefore, only GPCR comprising sequences identified by SEQ ID NO:, but not the full breadth of the claim meets the written description provision of 35 U.S.C. § 112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1646