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 .
Claim Status
Claims 1-17 are pending. Claims 1-3, 5-6, and 12-13 are withdrawn. Claims 4, 7-11, and 14-17 are presently considered.
Election/Restrictions
Applicant’s election without traverse of Group II (methods of preventing or treating neurodegeneration in a subject, original claims 4-20) in the reply filed on 7/25/2025 is acknowledged.
Applicant failed to elect a single species of Group II as required in three prior requests reiterating a species requirement1. However, it is the Examiner’s understanding that Applicant has identified a patentably indistinct subgenus of species (i.e., obvious variants) of methods in part with respect to amendments filed 7/25/2025, corresponding to disclosures at “published application, para. [0044]-[0046], [0052]-[0058], [0066], [0084], [0095]-[0098]” utilizing any possible, functionally defined “anti-Tat siRNAs”, consistent with amended claims 4 and 11 (see, e.g., MPEP § 818.02).
Therefore, in view of claims 4, 11, and the Applicant’s response filed 7/25/2025, the elected subgenus of patentably indistinct species (i.e., obvious variants) is understood to include the methods of
4. (Currently amended) A method of preventing and/or treating dementia in a subject, comprising: administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a[[n]] Tat siRNA agent which decreases Tat expression as compared to a control thereby decreasing interaction between human immunodeficiency virus (HIV) Tat protein[[,]] and Bcl-2 associated athanogene (BAG) , thereby preventing or treating dementia in the subject.
11. | (Currently amended) A method of preventing or treating neurodegeneration in a subject, comprising: administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a[n] Tat siRNA agent which decreases Tat expression as compared to a control thereby decreasing interaction between human immunodeficiency virus (HIV) Tat protein[[,]] and Bcl-2 associated athanogene (BAG) , thereby preventing or treating dementia in the subject.
However, Applicant did not identify which claims of Group II read upon the single species corresponding to paragraphs [0044]-[0046], [0052]-[0058], [0066], [0084], [0095]-[0098] of US2022/0088127A1 as required by the Requirement (see, e.g., Requirement mailed 5/14/2025 at 4-6). Critically, the elected subgenus was not specifically identified as reading upon claims 5-6 or 12-13, and the limitations of these claims is not identified or reduced to practice at the identified disclosures of the published Application. Accordingly, the originally elected subgenus of patentably indistinct species is understood to read upon instant claims 4, 7-11, and 14-17, but is not reasonably inferred to read upon instant claims 5-6 or 12-13.
Claims 1-3 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 filed on 7/25/2025.
Following extensive search and examination, the originally elected species has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 5-6 and 12-13 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are withdrawn.
During the search and examination of the originally elected species, art pertinent to other non-elected species was incidentally discovered. Although examination has not been extended beyond the non-elected species identified above per MPEP § 803.02, as a courtesy to the Applicant, this art has been applied below.
Claims 4, 7-11, and 14-17 are presently considered.
Information Disclosure Statement
The IDS filed 7/13/2021 is acknowledged and presently considered.
The listing of references in the specification is not a proper information disclosure statement (see, e.g., Spec. filed 7/13/2021 at 43-48). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections to Specification
The disclosure is objected to because of the following informalities:
The Specification incorrectly refers to colors in the black and white drawings of record (see, e.g., Spec. filed 7/13/2021 at 13 at 1st partial ¶, referring to “blue graphs”; 13 at 1st partial ¶, referring to “red graphs”).
Appropriate correction is required.
Objection to Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show to colors in the black and white drawings of record (see, e.g., Spec. filed 7/13/2021 at 13 at 1st partial ¶, referring to “blue graphs”; 13 at 1st partial ¶, referring to “red graphs”). as described in the specification.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Denial of 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. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) 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, US Provisional Application 62/792682 (filed 1/15/2019) 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.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Claims 4 and 11 are representative of the pending claim scope. Neither claim literally appears in Pro’682, and therefore the claims lack literal support in the Pro’682. For example, the phrases “Tat siRNA agent”, “therapeutically effective amount of a Tat siRNA agent”, and “decreases Tat expression as compared to a control thereby decreasing….” are all literally absent from Pro’682.
Accordingly, Pro’682 fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’682 through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in Pro’682, at least because the instant claims are indefinite (see rejections set forth below under 35 USC 112(b)), and zero examples of any method as claimed were reduced to practice implicitly, inherently, or literally wherein any disclosed “Tat siRNA agent” was administered to a subject at any dosage via any route of administration, and therefore zero examples of any methods satisfying the functional limitation of instant claims 4 and 11 were provided in Pro’682 using synonymous or equivalent language.
According the claim language presently claimed is not supported by the provisional document by synonymous or equivalent language.
Accordingly, Pro’682 fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to US Provisional Application 62/792682 (filed 1/15/2019) is denied for claims 4, 11, and all of the dependents of those claims; these claims have been accorded a priority date of 1/15/2020, which corresponds to the filing date of PCT/US2020/013724.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claims 4 and 11 are representative of the pending claim scope and presently recites:
4. (Currently amended) A method of preventing and/or treating dementia in a subject, comprising: administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a[[n]] Tat siRNA agent which decreases Tat expression as compared to a control thereby decreasing interaction between human immunodeficiency virus (HIV) Tat protein[[,]] and Bcl-2 associated athanogene (BAG) , thereby preventing or treating dementia in the subject.
11. | (Currently amended) A method of preventing or treating neurodegeneration in a subject, comprising: administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of a[n] Tat siRNA agent which decreases Tat expression as compared to a control thereby decreasing interaction between human immunodeficiency virus (HIV) Tat protein[[,]] and Bcl-2 associated athanogene (BAG) , thereby preventing or treating dementia in the subject.
Accordingly, the scope of claims 4 and 11 appear to substantially overlap. Applicable claim interpretations are set forth below.
Regarding the preamble of claims 4 and 11 (“of preventing and/or treating dementia in a subject” or “of preventing or treating neurodegeneration in a subject”), per MPEP § 2111.02, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”. Here, the body of claims 4 and 11 are understood to recite a structurally complete invention, and therefore the preamble is deemed fully satisfied by prior art that satisfies the steps and structures recited in the body of the claim (see also MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”).
Regarding the phrase at claims 4 and 11 reciting
…which decreases Tat expression as compared to a control thereby decreasing interaction between human immunodeficiency virus (HIV) Tat protein and Bcl-2 associated athanogene (BAG), thereby preventing or treating dementia in the subject…
Per MPEP § 2111.04(I), “[c]laim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”. Here, this language does not correspond to a structure/function relationship of record, and therefore is not reasonably interpreted to be a functional limitation. Accordingly, this language is understood to be a “whereby” clause that recites hoped for and desired results that Applicant wishes for the invention to achieve, but not structural limitations impacting the steps or chemical structures involved. Accordingly, this phrase is understood to be fully satisfied by the positively recited steps set forth in the body of claims 4 and 11, namely
…administering to the subject a pharmaceutical composition comprising a therapeutically effect amount of a Tat siRNA agent…
Accordingly, prior art teaching or suggesting any form of administration of any pharmaceutical composition comprising any therapeutically effective amount of any Tat siRNA agent to a subject in need of prevention or treatment of dementia, is understood to satisfy the recitation of intended and expected results set forth at claims 4 and 11.
Regarding the “wherein” clauses at dependent claims 7-10 and 14-17: It is prima facie unclear if the “wherein” clauses at dependent claims 7-10 and 14-17 are functional limitations or merely recitations of intended results, fully satisfied by the positively recited limitations set forth in the independent claim. This is problematic because, if the claims do not further limit the scope of the independent claims, then claims 7-10 and 14-17 are properly rejected under 35 USC § 112(d); however, if the “wherein” clauses represent functional limitations, then they must reasonably inform artisans of what structures are included or excluded from the pending claim scope, such that an artisan is capable of differentiating between infringing and non-infringing subject matter (see, e.g., MPEP § 2173, § 2173.05(g)). Because it is unclear if the “wherein” clauses constitute functional limitations, claims 7-10 and 14-17 have been rejected under 35 USC § 112(a) and § 112(b) under the presumption that the claims are directed to functional limitations, but also under § 112(d) and § 103 under the presumption that the “wherein” clauses merely recite intended and expected results fully satisfied by the positively recited method steps set forth in the body of the independent claims. This is reasonable because the “wherein” clauses may be presumed to be functional limitations that further limit the scope of the independent claims by further restricting the exact chemical structure of “Tat siRNA agent”, exact dosage, exact dosing frequency, exact pharmaceutical composition, exact administration route, etc. However, the “wherein” clauses at dependent claims 7-10 and 14-17 do not appear to unambiguously correspond to any clear structure/function relationship in the original disclosure, which does not weigh in favor of interpreting such “wherein” statements as functional limitations. Notably, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the “wherein” clause at dependent claims 7-10 and 14-17 do not unambiguously correspond to a clear structure/function relationship in the original disclosure, and therefore the “wherein” clauses may be reasonably inferred to merely recite an intended or expected result fully satisfied by all embodiments defined by the positively recited steps and/or structures set forth in the body of the independent claim (see 35 USC § 112(d)). For purposes of applying prior art under 35 USC §102 or §103, the “wherein” clauses of claims 7-10 and 14-17 are understood to be fully satisfied by all prior art embodiments that satisfy the positively recited steps set forth in the body of the independent claims.
Additional claim interpretations are set forth below.
Claim Rejections
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 4, 7-11, and 14-17 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.
Claim 4 and 11 refer to a genus of compounds by the term “Tat siRNA agent”, which renders the claim scope indefinite. The phrase “Tat siRNA agent” does not literally appear in the originally filed disclosure and therefore is not specifically defined on record. The phrase “Tat siRNA agent” is understood to include functional language, wherein the phrase defines a genus of “siRNA agents” by reference to a target (i.e., Tat) that they hope and desire to target2, but in the complete absence of actual structures capable of achieving such function. SiRNAs differ with respect to length, sequence compositions, sequence complementarity to a target, etc. Given a 22-mer to 26-mer siRNA, there are 422 to 426 possible sequences, and the relevant issue is distinguishing which of those are included or excluded from the genus of “Tat siRNA agents” such that an artisan can distinguish infringing from non-infringing embodiments since the courts have stated
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Here, an artisan would not be able to distinguish between infringing and non-infringing species of “Tat siRNA agents” in the absence of clarification, because if the genus reads upon any siRNA sharing “at least five consecutive bases complementary to a nucleic acid sequence” (see, e.g., Spec. filed 7/13/2021 at 19-20 at bridging ¶), then given a 22-mer to 26-mer siRNA, there would be 417 to 421 possible sequences (>>17 billion). However, if full complementarity is required with a target (see, e.g., Spec. filed 7/13/2021 at 20 at lines 7-20), then the genus of “Tat siRNA agents” as claimed could only encompass a few thousand possible siRNAs at most (i.e., <47)3. This lack of clarity regarding the metes and bounds of the genus of “Tat siRNA agents” is pertinent because close prior art exists, including Surabhi et al.4 discloses siRNAs that target HIV-1 Tat (see, e.g., Surabhi at abs, 12964 at col I-II at bridging ¶, Fig. 1 on 12966); Coburn et al.5 discloses siRNAs that target HIV-1 Tat (see, e.g., Coburn at abs, Fig. 1 on 9226, 9230 at col I at 1st partial ¶); and US20050020521 A1 discloses siRNA strategies targeting HIV Tat (see, e.g., US’521 at ¶[0370]). These references are not exhaustive. Furthermore, it is unclear if “Tat siRNA agents” include siRNAs that target other non-Tat oligonucleotides, that then cause Tat levels to decrease. Per MPEP § 2173.05(g), 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. Here, it is prima facie unclear what exact structures of “Tat siRNA agents” are included or excluded from the pending claim scope, and the scope of sequences encompassed by “Tat siRNA agents” may range from 422 to 426 possible sequences or more, or perhaps only a few thousand sequences (i.e., <47), or perhaps less than a dozen that are capable of “treating or preventing dementia” in subjects. Accordingly, in the absence of clarification and clear metes and bounds, an artisan would be unable to distinguish infringing embodiments from non-infringing embodiments (see, e.g., University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004), quoted above). Accordingly, claims 4, 11, and all claims reciting “Tat siRNA agents” are rejected as indefinite because the phase lacks clear metes and bounds permitting an artisan to distinguish between infringing and non-infringing embodiments, and close prior art exists. For purposes of applying prior art, all prior art recognized sequences having at least five consecutive residues of complementarity with Tat HIV mRNA are understood to be “Tat siRNA agents”, which is reasonable in view of the description regarding siRNAs in the instant disclosure (see, e.g., Spec. filed 7/23/2021 at 19-20 at bridging ¶).
Claims 4 and 11 recite the phrase “..a Tat siRNA agent which decreases Tat expression as compared to a control…”, which renders the claims indefinite. “Compared to a control” is a variable, functional limitation that changes meaning entirely if the “control” being referenced is a positive control or a negative control. Per MPEP § 2173.05(b)(II), reference to a variable object may render a claim indefinite when the relationship is not sufficiently defined. Here, the relationship is unknown because the control is unspecified and the specifics of the control materially and substantially alter the effectiveness of the Tat siRNA (i.e., if it is a negative control, then the agent needs only to be minimally active to satisfy the functional limitation at issue, but if the control is positive, then the agent will need to be more effective than the positive control itself to satisfy the functional limitation at issue). Accordingly, claims 4 and 11 are rejected as indefinite. For purposes of applying prior art, the applicable claim interpretation has been set forth in the claim interpretation section above. In brief, any and all siRNAs capable of targeting Tat and capable of decreasing tat expression to any extent relative are understood to necessarily satisfy the limitations regarding a “control” as recited at instant claims 4 and 11.
Claims 4 and 11 recite the phrase “therapeutically effective amount”, which renders the claim scope indefinite. Per MPEP § 2173.05(d)(III),
The common phrase "an effective amount" may or may not be indefinite. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure.
Here, zero examples of any method as claimed were reduced to practice, the discussions regarding therapeutic compounds in subject is theoretical and prophetic only (see, e.g., Spec. filed 7/13/2021 at 27 at lines 5-16), “effective amount” is defined merely by reference to a desired and hoped for result (see, e.g., Spec. filed 7/13/2021 at 5 at lines 21-22), and zero structures constituting a “Tat siRNA agent” were actually disclosed or reduced to practice on record. Accordingly, it is prima facie unclear what does or does not constitute a “therapeutically effective amount” of any specific species of “Tat siRNA agent” formulated with a specific pharmaceutically acceptable carrier for delivery via a specific delivery route, sufficient and capable of “preventing or treating dementia in [a] subject” as presently claimed. Accordingly, per MPEP § 2173.05(d)(III), an artisan would be completely unable to “determine specific values” that do or do not constitute a “therapeutically effective amount” of unknown “Tat siRNA agents” sufficient to “prevent[] or treat[] dementia” in subjects. Accordingly, claims 4 and 11 are rejected as indefinite. For purposes of applying prior art, any amount taught in the prior art for any art-recognized siRNA capable of targeting HIV Tat is presumed “therapeutically effective” to achieve all functional results recited at instant claims 4, 7-11, and 14-17.
Claims 7-10 and 14-17 are dependent claims differing from the independent claims only by the recitation of a “wherein” clause (see, e.g., instant claims 4, 7-11, and 14-17). Ostensibly, such “wherein” clauses may refer to functional limitations, wherein the scope of the dependent claim must be narrowed relative to the independent claim to satisfy 35 USC § 112(d). For the instant rejection, it is assumed that the “wherein” clauses are functional limitations that further narrow the scope of the independent claim. Per MPEP § 2173.05(g), 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. Accordingly, a basic question is simply “what embodiments within the independent claim are excluded from the scope of the dependent claim in view of the functional limitation?” Here, zero structure/function relationships corresponding to the “wherein” clauses is found on record; zero examples of any method as claimed were reduced to practice6; and zero structures constituting a “Tat siRNA agent” were actually disclosed or reduced to practice on record. Accordingly, assuming that the genus of “Tat siRNA agent” encompasses a few thousand sequences (i.e., <47) to >> billion sequences (>417) (see discussion above), it is unclear which specific “Tat siRNA agents”, in any specific formulation and dosage, and administration route, are sufficient to satisfy the potential functional limitations set forth in dependent claims 7-10 and 14-17. This is pertinent because the courts have stated
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Here, an artisan would not be able to distinguish between infringing and non-infringing species that read upon an independent claim but are excluded from the presumably narrower scope of dependent claims 7-10 and 14-17. For purposes of applying prior art, in the complete absence of any structure/function relationship, the “wherein” clauses at dependent claims 7-10 and 14-17 have been interpreted as recitations of intended and expected results fully satisfied by all possible embodiments satisfying the positively recited limitations set forth in the body of the independent claim7, namely the “wherein” clauses of claims 7-10 and 14-17 are understood to be fully satisfied by any prior art embodiment requiring the administering to subject in need of treatment for dementia a pharmaceutical composition comprising a therapeutically effect amount of a Tat siRNA agent.
Claims 7-10 and 14-17 depend directly or indirectly upon either independent claim 4 or 11, which have been rejected as indefinite above. The dependent claims fail to reconcile or clarify the indefiniteness of the base claim, and therefore the dependent claims are rejected for the reasons applied to the base claims.
Claims 4, 7-11, and 14-17 are rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-10 and 14-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 7-10 and 14-17 have been rejected as indefinite (see, e.g., rejections under 35 USC 112(b), above, discussion incorporated into the instant rejection). For purposes of the instant rejection, the “wherein” clauses at claims 7-10 and 14-17 are understood to merely recite intended and expected uses, that fail to further limit any structures or steps positively recited in the body of independent claims 4 or 11, respectively8. This is reasonable because none of the “wherein” clauses correspond to any structure/function relationship of record, and therefore do not appear to be further limiting functional limitations. Accordingly, all “wherein” clauses at claims 7-10 and 14-17 are understood to fail to further limit the subject matter of the claim upon which they depend, and therefore be properly rejected under 35 USC §112(d).
If Applicant disagrees, Applicant is invited to identify exactly what exact embodiments of methods (i.e., structures, dosages, administration routes, structures) within the scope of the independent claims are excluded by the “wherein” clauses of each dependent claim, wherein such guidance is commensurate in scope with a structure/function relationship of record.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a), New Matter
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 4, 7-11, and 14-17 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Scope
Claims 4 and 11 are representative of the pending claims scope. Claims 4 and 11 are not original claims and were amended in the Reply filed 7/25/2025. The applicable claim interpretations have been set forth above under 35 USC § 112(b) and in a separate claim interpretation section. Those discussions are incorporated herein.
Applicable Case Law
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Lack of literal Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163.
Claims 4 and 11 do not literally appear in the originally filed disclosure. For example, the phrases “Tat siRNA agent”, “therapeutically effective amount of a Tat siRNA agent”, and “decreases Tat expression as compared to a control thereby decreasing….” are all literally absent from the originally filed disclosure.
Accordingly, the originally filed disclosure fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP 2163. As noted above, the claims are not literally supported by the originally filed disclosure. Accordingly, the relevant issue is whether or not the new amendments and resulting claim scope is implicitly or inherently supported by the originally filed disclosure.
Per MPEP § 2163(I)(B), “[a]n amendment to correct an obvious error does not constitute new matter where the ordinary artisan would not only recognize the existence of the error in the specification, but also recognize the appropriate correction. In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA 1971)”. Here, no allegation that the amendments correct an obvious error has been made. Furthermore, upon inspection, Examiner is unable to identify any single “obvious error” that would lead to the instantly amended claim scope. Accordingly, the amendments cannot be said to correct an “obvious error”.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in the originally filed disclosure. Notably, the instant claims are indefinite (see rejections set forth below under 35 USC 112(b)), and zero examples of any method as claimed were reduced to practice implicitly, inherently, or literally wherein any disclosed “Tat siRNA agent” was administered to a subject at any dosage via any route of administration. Notably zero structure/function relationships corresponding to the “wherein” clauses of dependent claims 7-11 and 14-17 are found on record; zero examples of any method as claimed were reduced to practice9; zero structures constituting a “Tat siRNA agent” were actually disclosed or reduced to practice on record; and what amount of any particular “Tat siRNA agent” constitutes an “effective amount” is, at best, defined only by reference to a desired and hoped for result (see, e.g., Spec. filed 7/13/2021 at 5 at lines 21-22). Accordingly, zero inherent or implicit disclosures of record commensurate in scope with the instantly claimed invention were actually reduced to practice on record.
Conclusion
Per MPEP § 2163, new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement (see, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971)). Here, the newly added claim limitations are not inherently, implicitly, or literally supported by the originally filed disclosure.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789). Likewise, in the instant case, the claims are directed to methods of treating a functionally defined genus of diseases using unknown amounts of untested compounds, and have only identified generically “goals [Applicant] hope the claimed invention achieves”, and left it completely to others to actually invent and discover the specifics of the methods Applicant has attempted to claim.
Accordingly, claims 4, 7-11, and 14-17 are rejected as directed to new matter.
Claim Rejections - 35 USC § 112(a), Written Description
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 4, 7-11, and 14-17 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Brief Statement of the Issue(s)
The amended claims filed 7/25/2025 attempt to claim an invention defined using functional language that does not reasonably correspond to known steps or structures of record.
Claim Scope
Claims 4 and 11 are representative of the pending claims scope and recite a method of “preventing” and/or “treating” neurodegeneration in patients, and specifically dementia, by administering an unspecified dosage, via an unspecified route, of an unspecified pharmaceutical composition comprising an undisclosed siRNA (“Tat siRNA agent”) of unknown length, unknown composition, and unknown target complementarity, wherein such administration is intended and hoped to result in “preventing or treating dementia in the subject”.
The applicable claim interpretations have been set forth above under 35 USC 112(b), §112(d), §112(a) and in a separate claim interpretation section. Those discussions are incorporated herein.
It is unclear if the claimed methods encompass trillions of species of methods, via all forms of administration (e.g., topical, anal, oral, intramuscular, intravenous, etc.), of treating all forms of neurodegeneration and dementia in any mammalian subject using any one of potentially billions and trillions of “Tat siRNA agent” (>> billion sequences (>417))10; or if instead the claimed methods only include and work under stringent conditions such as one route of administration only in patients at risk of HIV-related dementia, at a specific and narrow “therapeutically effective” dosage, and using only a few dozen (or less) siRNA sequences. Accordingly, the claim scope appears to be vast and highly varied.
Actual Reduction to Practice
Zero embodiments of the claimed invention of claims 4, 7-11, and 14-17 were reduced to practice, and zero “subjects” were tested in any in vivo mammalian patient population.
Zero examples of any method as claimed were reduced to practice implicitly, inherently, or literally wherein any disclosed “Tat siRNA agent” was actually administered to any mammalian subject at any dosage via any route of administration, and shown to achieve any treatment or prevention of dementia11.
Zero structure/function relationships corresponding the clause at claims 4 and 11 reciting
…which decreases Tat expression as compared to a control thereby decreasing interaction between human immunodeficiency virus (HIV) Tat protein and Bcl-2 associated athanogene (BAG), thereby preventing or treating dementia in the subject…
were disclosed on record.
Zero structure/function relationships corresponding to the “wherein” clauses of dependent claims 7-11 and 14-17 are found on record;
Zero guidance of what structures do or do not constitute a “Tat siRNA agent” were actually disclosed or reduced to practice on record.
Zero guidance regarding what exact doses and dosage range for any particular species of “Tat siRNA agents” that constitutes an “effective amount” as claimed was provided in the originally filed disclosure. At best, “effective amount” is defined only by reference to a desired and hoped for functional result that the unspecified dosage is hoped to acheive (see, e.g., Spec. filed 7/13/2021 at 5 at lines 21-22).
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
As noted above, in the instant case the claim is vast and highly varied because there is substantial variation in the (i) composition administered (i.e., carriers, excipients, additional therapeutics), (ii) structure of “Tat siRNA agent” (i.e., potentially >> 17 billion), (iii) route of administration (i.e., oral, intraocular, sublingual, rectal, topical, etc.), (iv) dosage (i.e., some unknown and undisclosed “effective amount”), (v) dosing frequency (i.e., twice daily, once weekly, once monthly, etc.), (vi) patient population (i.e., any patient in need of prevention of dementia, including HIV patients, cancer patients, geriatric patients, etc.). Therefore, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, Applicant merely describes a laundry list disclosure of what they hope to achieve, but fail to actually disclose any particulars regarding dosage, structures, etc., and fail to provide even a single working example of the claimed invention, or even a single example of a “Tat siRNA agent” as required by the claims. As noted above, zero examples of the claimed invention, workable “effective amounts”, or structures that do or do not constitute a “Tat siRNA agent” were actually disclosed on record.
Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of zero species within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, the disclosure of zero examples of the claimed invention does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
Identifying characteristics of the genus
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A basic threshold question is simply, “what does or does not constitute a ‘Tat siRNA agent’ within the scope of the instant claims?” However, the originally filed disclosure fails to provide any guidance regarding what structures do or do not constitute a “Tat siRNA agent” within the scope of the instant claim (see, e.g., discussions and rejections above, under 35 USC § 112(b), incorporated herein). Accordingly, the phrase “Tat siRNA agent” is a genus of potentially a few dozen or a few trillion siRNAs, which are functionally defined by the target they are intended to target. Accordingly, it is prima facie unclear what exact structures of “Tat siRNA agents” are included or excluded from the pending claim scope, and the originally failed disclosure fails to provide meaningful guidance informing artisans of the metes and bounds of the invention. Accordingly, an artisan is simply left to guess at what exact structures (from potentially >422 to >426 possible sequences) are capable of performing the method as claimed and treating or preventing dementia.
Another threshold question is simply, “how much of a ‘Tat siRNA agent’ should be administered to achieve treatment or prevention of dementia?” The originally filed disclosure fails to actually disclose a single working example of the claimed invention, or otherwise disclose any “therapeutically effective amount” of any particular “Tat siRNA agent” actually capable of achieving the results recited in the pending claims12 (see, e.g., discussions and rejections above, under 35 USC § 112(b), incorporated herein). Accordingly, it is prima facie unclear what does or does not constitute a “therapeutically effective amount” of any specific species of “Tat siRNA agent” formulated with a specific pharmaceutically acceptable carrier for delivery via a specific delivery route, sufficient and capable of “preventing or treating dementia in [a] subject” as presently claimed.
In addition, the “wherein” clauses at dependent claims 7-10 and 14-17, ostensibly recite functional limitations, wherein the scope of the dependent claim must be narrowed relative to the independent claim to satisfy 35 USC § 112(d). Therefore, a basic threshold question for understanding such functional limitations is, “How does this functional limitation limit the claim scope?” or “What embodiments of the independent claim are excluded by the narrowing functional limitation in the dependent claims?” However, the “wherein” clauses fail to correspond to any structure/function relationships that limit any aspect of the claimed invention in a clear, unambiguous manner (see, e.g., discussions and rejections above, under 35 USC § 11