DETAILED ACTION
Claims 2, 5, 14-17, 21, and 26-33 are pending.
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 filed 7/14/2023 is a National Stage entry of PCT/US22/12516, International Filing Date of 1/14/2022. PCT/US22/12516 Claims Priority from Provisional Application 63137915, filed 1/15/2021.
Election/Restrictions
Applicant's election with traverse of Group I (claims 2, 5, 14-17, and 21) in the reply filed on 3/13/2026 is acknowledged. The traversal is on the ground(s) that the application contains a limited number of claims, all of which can be searched and examined without a serious burden. This is not found persuasive because the claims are directed to multiple different inventions as a CRISPR system against SIGIARI, a siRNA, a shRNA, a microRNA, a antisense polynucleotide, a small molecule chemical compound are all in different classifications and do not share a core structure making a search of each one unique. Each one will have different search strategies and this is a serious search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 26-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
Applicant's election with traverse of “Compound G” without traverse is noted for examination purposes, claims 16 and 17 are not directed to treatment with a small molecule and are therefore withdrawn.
Claims 2, 5, 14, and 21 are present for Examination and the subject of the Office Action below.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 12/11/2023, 12/23/2024, and 2/12/2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
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 2, 5, 14, and 21 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.
In claim 2 applicant claims “an agent that reduces or prevents SIGMAR1 transcription, or reduces or inhibits Sigma1 activity or expression, in the subject.”
This recitation, is purely functional in nature. The claim doesn’t posit any structural requirement, only a function (to reduce or prevent to a specific gene or protein). See MPEP 2173.05(g). The language used does not modify a structure, but is the only language provided to define the structure. The use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234 (1942) (holding indefinite claims that recited substantially pure carbon black "in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior"). In this case the language simply recites a function or result achieved by the invention, and therefore the metes and bounds of the claim are not defined.
Claim 15 attempts to remedy the purely functional claiming by further limiting “the agent” to a series of known active agents in the art. For example the “(a)” embodiment is directed to a CRISPR system. Applicant then states that any and all CRISPR inventions directed to the function that reduces or prevents SIGMAR1 transcription, or reduces or inhibits Sigma1 activity or expression, in the subject would be included in the scope of the invention, see the Specification on Page 35. The problem is, the generic claiming of a CRISPR system is not defined in a way to inform the public as to the metes and bounds of the invention. This is based on the ambiguous and generic nature of the language. For example the art recognizes that even when using one specific (and most studies form) of CRISPR, that using Cas9 one has to validate the effect and understand and measure how much the gene is disabled. Applicant has not informed the public as to the extent of disablement that is required leaving this term undefined.
This is true for the compounds as well (instant claim 15 (b)). For example, it is well established that individual compounds will have different specificity for targeting Sigma1 relative to Sigma2, and off target effects. The compounds will all have different pharmacokinetic profiles and different toxicity profiles, none of which applicant has defined by simply giving a structural genus of potential compounds having some activity on Sigma1 inhibition. A person of ordinary skill would not be able to ascertain from the teaching what compounds are included in the genus and what are excluded, as no one would look at the genus of the more than a quadrillion compounds in embodiment (b) alone and know the metes and bounds of compounds capable of performing the invention of “of treating, ameliorating, preventing a disease or condition…” such as “hepatic steatosis (fatty liver) or an inflammation associated with steatohepatitis; nonalcoholic fatty liver disease (NAFLD); or nonalcoholic steatohepatitis (NASH).” Applicant has not defined the nessasary function to achieve this result and therefore the metes and bounds of the “agents” are not known.
Claim Rejections - 35 USC § 112(a)
Lack of Written Description, and Lack of Enablement
Claim 2 is rejected under 35 U.S.C. 112(a) because the claimed “an agent that reduces or prevents SIGMAR1 transcription, or reduces or inhibits Sigma1 activity or expression, in the subject.” is a purely functional recitation with no limitation of structure. The limitation is similar to claiming, any structure with means for treating cardiovascular disease. The claims are thus genus claims, encompassing the use of all substances that achieve the desired result of being a cardiovascular agent. Please see, Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure. In this Application both problems exist.
Section 1 12 requires that the patent specification enable "those skilled in the art to make and use the full scope of the claimed invention without 'undue experimentation' " in order to extract meaningful disclosure of the invention and, by this disclosure, advance the technical arts. Koito Mfg. [Co., Ltd. v. Turn-Key-Tech, LLC], 381 F.3d [I1421 at 1155 [(Fed. Cir. 2004)l (quoting Genentech, Inc. v. Novo Nordisk A , , 108 F.3d 1361, 1365 (Fed.Cir. 1997) (citation omitted)). Because such a disclosure simultaneously puts those skilled in the art on notice of the enforceable boundary of the commercial patent right, the law further makes the enabling disclosure operational as a limitation on claim validity. "The scope of [patent] claims must be less than or equal to the scope of the enablement. The scope of enablement, in turn, is that which is disclosed in the specification plus the scope of what would be known to one of ordinary skill in the art without undue experimentation." Nat'l Recovery [Techs., Inc. v. Magnetic Separation Sys., Inc. 1, 166 F.3d [I1901 at 1196 [(Fed. Cir. 1999)l; see also In re Goodman, 1 1 F.3d 1046, 1050 (Fed.Cir. 1993) (" [Tlhe specification must teach those of skill in the art 'how to make and how to use the invention as broadly as it is claimed'."); In re Fisher, 57 C.C.P.A. 1099,427 F.2d 833, 839 (1970) ("[Tlhe scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art.").
Invitrogen Corp. v. Clontech Labs. Znc, 429 F.3d 1052, 1070-71 (Fed. Cir.
2005) (footnote omitted).
Undue Experimentation - Wands Factors
Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.
In re Wands, 858 F.2d at 737.
The Wands factors 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 unpredictability of the art, and (8) the breadth of the claims.
Id.
In reviewing for lack of enablement, the Wands court elected to consider "all of the factors." Id. at 740. However, it is not necessary to review all the Wands factors to find a disclosure enabling. Rather, the Wands factors "are illustrative, not mandatory" and what is relevant to an enablement determination depends upon the facts of the particular case. See Amgen, Znc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991). See also Enzo Biochem, Znc. v. Calgene, Znc., 188 F.3d 1362, 1373 (Fed. Cir. 1999) and Warner-Lambert Company v. Teva Pharmaceuticals USA, Inc., 418 F.3d 1326, 1337 (Fed. Cir. 2005).
Functional Claiming versus 35 U.S. C. § 112, sixth paragraph
When a claim uses the term “means” to describe a limitation, a presumption inheres that the inventor used the term to invoke § 112, ¶ 6. Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1375 (Fed. Cir. 2003). “This presumption can be rebutted when the claim, in addition to the functional language, recites structure sufficient to perform the claimed function in its entirety.” Id.
As the court set forth in LG Electronics:
" '[A] claim term that does not use 'means' will trigger the rebuttable presumption that § 112 ¶ 6 does not apply.' " Lighting World, Inc. v. Birchwood Lighting, Inc., 382 F.3d 1354, 1358 (Fed. Cir. 2004) (quoting CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1369 (Fed. Cir. 2002)). This presumption can be rebutted "by showing that the claim element recite[s] a function without reciting sufficient structure for performing that function." Watts v. XL Sys., 232 F.3d 877, 880 (Fed. Cir. 2000) (citing Rodime PLC v. Seagate Tech., Inc., 174 F.3d 1294, 1302 (Fed. Cir. 1999)). However, the presumption "is a strong one that is not readily overcome." Lighting World, Inc., 382 F.3d at 1358.
LG Electronics, Inc. v. Bizcom Electronics, Inc., 453 F.3d 1364, 1372
(Fed. Cir. 2006).
Because the Applicant did not use “means” to recite the limitation (“an agent that reduces or prevents SIGMAR1 transcription, or reduces or inhibits Sigma1 activity or expression, in the subject.”) in claim 2, the presumption is that the Applicant did not intend to invoke interpretation of “cardiovascular agent” under § 112, sixth paragraph.
Applicant is reminded that 35 U.S.C. § 112, sixth paragraph, when enacted, was a statutory response to the Supreme Court’s decision in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946).
This general prohibition against the use of “purely functional claim language” (and the more specific Halliburton rule) has not been completely eliminated. Rather, “purely functional claim language” is now permissible but only under the conditions of 35 U.S.C. § 112, sixth paragraph, i.e., if its scope is limited to the corresponding structure, material, or act disclosed in the specification and equivalents thereof.
In the absence of such limited construction, the concerns expressed by the Court in Halliburton are still applicable to prohibit the use of “purely functional” claim language. Hence, any claim that includes purely functional claim language, and which is not subject to the limited construction under 35 U.S.C. § 112, sixth paragraph, fails to meet the requirements of 35 U.S.C. § 112, first paragraph, according to reasoning in Halliburton and thus is unpatentable.
While the particular claim language involved in the Supreme Court's Halliburton decision uses the word “means,” the issue was claiming in a purely functional manner, a practice condemned by pre-existing case law, and not any particular problem associated uniquely with the word “means” as distinguished from other purely functional words and phrases. With regard to pre-existing case law around the time of the Supreme Court's Halliburton decision, see In re Fuetterer, 319 F.2d 259, 263 (CCPA 1963), wherein the Court of Customs and Patent Appeals explained:
In the Fullam case [In re Fullam, 161 F.2d 247 (CCPA 1947)], this court stated that some claims were properly rejected as “functional in claiming merely the desired result well known to and sought after by workers skilled in the art.” Claims directed merely to a “desired result” have long been considered objectionable primarily because they cover any means which anyone may ever discover of producing the result. See, e.g., O'Reilly v. Morse, 15 How. 62; Heidbrink v. McKesson, 290 F. 665.
When an applicant has not given notice to the public that his or her purely functional claim element is to be limited by the application of 35 U.S.C. § 112, sixth paragraph, a first USPTO concern is that the claim is indefinite under 35 U.S.C. § 112, second paragraph. A second USPTO concern is that such unlimited purely functional claiming may reasonably be construed to encompass any and all structures for performing the recited function, including those which are not what the applicant invented. Thus, it is doubly critical that the USPTO be in possession/written description of such public notice when making a determination to grant a patent. That is, when the limitation encompasses any and all structures or acts for performing a recited function, including those which were not what the applicant had invented, the disclosure fails to provide a scope of enablement commensurate with the scope of the claim and the claim would violate the prohibition of Halliburton. (Again, Applicant lacks BOTH.)
The Supreme Court’s Halliburton case remains viable for claims having purely functional claim language which is unlimited either by (1) the application of 35 U.S.C. § 112, sixth paragraph, or (2) the additional recitation of structure.
In the present case, claim 1, recitation of “an agent that reduces or prevents SIGMAR1 transcription, or reduces or inhibits Sigma1 activity or expression, in the subject.” violates the rule set forth in Halliburton, because the claims are not limited by the application of 35 U.S.C. § 112, sixth paragraph, and they do not contain any additional recitation of structure. As such, these claims are unpatentable under 35 U.S.C. § 112, first paragraph, for lack of an enabling disclosure commensurate with the scope of the claims. The breadth of the functional limitation must be commensurate with the scope of the supporting disclosure.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2, 5, 14, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim, WO 2014/015157 A2 which teaches “Compound G” as a Sigma1 inhibitor.
Claim 2 is directed to the prevention of NASH by administration of “Compound G.”
Kim teaches the administration of “Compound G” to modulate the Sigma1 receptor, see claims 58-68. The scope of instant claim 2 includes any person, as prevention occurs by the inherent properties of the compound given to any person, as in prevention the patient does not have the disease or condition.
Instant claims 5, 14, and 21 do not narrow the patient and simply require the specific compound already addressed, and the subject being a human, which is taught by Kim. Therefore claims 2, 5, 14, and 21 are anticipated.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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