DETAILED ACTION
Disposition of Claims
Claims 1-23 are pending.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240277829A1, Published 08/22/2024.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Optional Authorization to Initiate Electronic Communications
The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/02/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the use of implied phraseology (e.g. “Methods are disclosed…”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 18 is objected to because of the following informalities: to place the claim in better form, it is suggested that “wherein the subject is a female human” be replaced with language identifying the relevant physical/anatomical characteristic, such as “wherein the subject has a vagina” since the claimed method requires intravaginal administration. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: to place the claim in better form, it is suggested that “the” before “HIV-1” at line 11 be deleted, and after “acquisition” in line 11 the word “by” or “in” should be inserted. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, and 21 and dependent claims 3-20 and 22-23 thereof 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 1, 2, and 21 recite a “deletion of HIV-1 Env residues 137-152 according to the HXBc2 numbering system” without identifying the amino acid sequence from which the residues are deleted. Claim 2 additionally comprises that the gp120 would comprise or consist of residues 31-507 according to the HXBc2 numbering system. Although the HXBc2 numbering may be a recognized reference system, the claims do not recite a particular Env sequence, strain, clade, or SEQ ID NO:, and therefore do not clearly identify the structural boundaries of the claimed deletion of the recombinant gp120 protein. Additionally, as ¶[0077] and ¶[0078] identify SEQ ID NO:1 as being from both “HXB2” and “HXBc2”, it is unclear if SEQ ID NO: 1 refers to the frame-of-reference sequence indented for use.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 1, 2, and 21 are rejected on the grounds of being indefinite. Claims 3-20 and 22-23 are also rejected since they depend from claim(s) 1, 2, or 21, but do not remedy these deficiencies of claim(s) 1, 2, or 21.
Claim 3 is 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 3 is drawn to the method of claim 1, wherein the recombinant gp120 protein comprises or consists of any one of SEQ ID NOs: 1-3. Claim 1, however, notes that the gp120 protein must comprise a deletion of HIV-1 Env residues according to the HXBc2 numbering system. As SEQ ID NO:1 is the full-length gp120/Env sequence, it is unclear how said sequence can therefore comprise or consist of the full-length sequence. Note that in the specification, at ¶[0077-0078], the HXBc2 sequence for HIV-1 Env is noted as being SEQ ID NO: 1, making it the undeleted reference sequence.
One suggestion is to amend claim 3 along the lines of the following:
“3. The method of claim 1, wherein the recombinant gp120 protein comprises or consists of any one of SEQ ID NOs: 2-3.”
For at least these reasons, claim 3 is rejected on the grounds of being indefinite.
Claims 14-16 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 13 is drawn to the method of claim 1, and further limits claim 1 by stating the nucleic acid molecule encoding the recombinant gp120 is what is being delivered to the subject. With the wording of claims 14-16, which depend upon claim 13, it is unclear if the vector, RNA, and DNA are further limiting the nucleic acid of claim 13, or are additional items delivered with the nucleic acid of claim 13.
For at least these reasons, the metes and bounds of claims 14-16 are unclear.
Claim 17 is 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 17 is drawn to the method of claim 13, wherein the nucleic acid molecule encoding the recombinant gp120 encodes a gp160. However, it is unclear how the nucleic acid molecule “encoding the recombinant gp120” of claim 13 is further limited by “encodes a gp160”. A nucleic acid normally encodes a gp160 precursor that is processed into gp120/gp41, and with the claims stating that the nucleic acid molecule is encoding the recombinant gp120 and then a dependent claim states the same nucleic acid molecule encodes a gp160, this makes the relationship of the nucleic acids unclear. If Applicant intends the Env/gp160 construct yields a gp120, this is how it should be arranged, because as it stands, the claim does not clarify whether the nucleic acid encodes gp120, gp160, a gp160 precursor that is processed into gp120, or a construct comprising gp120 and gp41 regions.
For at least these reasons, the metes and bounds of claim 17 are unclear.
Claims 19 and 22 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 19 is drawn to “wherein the effective amount of the SAMT-247 microbicide is administered within four hours of a potential exposure to HIV”. However, the claim does not specify whether the SAMT-247 is administered before or after the potential exposure, or a period encompassing both before and after the potential exposure. The scope of the claimed timing limitation is therefore unclear.
Claim 22 is rejected for similar reasoning.
For at least these reasons, the metes and bounds of claims 19 and 22 are unclear.
Claim 21 and dependent claims 22-23 thereof 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 21 is drawn to a method of inhibiting HIV-1 acquisition in a subject, and claims a step of “applying intra-vaginally an effective amount of a SAMT-247 microbicide,” at line 10. However, it is not clear as to whom this step is performed upon (e.g. previous steps recite “administering to the subject a boost” or “administering to the subject an effective amount of a composition”), as not all subjects would reasonably have a vagina, so it is unclear if the microbicide is delivered to the subject, or to another subject.
For at least these reasons, claim 21 is rejected on the grounds of being indefinite. Claims 22-23 are also rejected for depending upon claim 21, but not clarifying the metes and bounds of claim 21.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
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.
Claim 3 is 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. As set forth supra, it is unclear how SEQ ID NO: 1 further limits claim 1 upon which it depends, as SEQ ID NO: 1 does not comprise a deletion of the HIV-1 Env residues 137-152. 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 Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1 is drawn to a method of inhibiting a human immunodeficiency virus (HIV) acquisition by a subject, comprising: administering to the subject an effective amount of a recombinant gp120 protein comprising a deletion of HIV-1 Envelope (Env) residues 137-152 according to the HXBc2 numbering system, or a nucleic acid molecule encoding the recombinant gp120 protein, wherein the recombinant gp120 protein elicits an immune response to HIV-1; and administering to the subject an effective amount of a SAMT-247 microbicide, thereby inhibiting HIV acquisition by the subject.
Further limitations on the method of claim 1 are wherein the recombinant gp120 protein comprises or consists of HIV-1 Env residues 31-507, with the deletion of residues 137-152, according to the HXBc2 numbering system (claim 2); wherein the recombinant gp120 protein comprises or consists of any one of SEQ ID NOs: 1-3 (claim 3); comprising administering to the subject a first composition comprising the effective amount of the recombinant gp120 protein and a pharmaceutically acceptable carrier, and a second composition comprising the effective amount of the SAMT-247 microbicide (claim 4), wherein the first composition and the second composition are administered to the subject by different routes (claim 5), wherein the second composition is administered to the subject by a vaginal or rectal route (claim 6), wherein the second composition is a suppository, a cream or a gel (claim 7), wherein the second composition is administered by the vaginal route using a vaginal ring delivery device (claim 8), wherein the second composition is formulated for oral administration and is administered orally to the subject (claim 9), wherein the first composition further comprises an adjuvant (claim 10), wherein the adjuvant comprises an aluminum adjuvant (claim 11), wherein the adjuvant comprises monophosphoryl lipid A and/or saponin QS21 (claim 12); comprising administering to the subject the effective amount of the nucleic acid molecule encoding the recombinant gp 120 (claim 13), comprising administering to the subject an effective amount of a vector encoding the recombinant gp120 (claim 14), comprising administering to the subject an effective amount of an RNA encoding the recombinant gp120 (claim 15), comprising administering to the subject an effective amount of a DNA encoding the recombinant gp120 (claim 16), wherein the nucleic acid molecule encoding the recombinant gp120 encodes a gp160 (claim 17); wherein the subject is a human and has a vagina, and wherein the effective amount of the SAMT-247 microbicide is administered intravaginally (claim 18); wherein the effective amount of the SAMT-247 microbicide is administered within four hours of a potential exposure to HIV (claim 19); and further comprising administering to the subject an effective amount of a booster vector encoding HIV-1 envelope (env) and polymerase (pol)(claim 20).
Claim 21 is drawn to a method of inhibiting HIV-1 acquisition in a subject, comprising:
administering to the subject an effective amount of a composition comprising a prime immunization of a DNA vector encoding HIV-1 Env with a deletion of HIV-1 Env residues 137- 152 according to the HXBc2 numbering system and an adjuvant,
administering to the subject a boost immunization of a vector encoding HIV env, HIV gag, and HIV pol and an alum adjuvant,
administering to the subject a boost immunization of a purified gp120 protein with a deletion of HIV-1 Env residues 137-152 according to the HXBc2 numbering system formulated with an effective amount of an alum adjuvant; and
applying intra-vaginally an effective amount of a SAMT-247 microbicide, thereby inhibiting HIV-1 acquisition the subject.
Further limitations on the method of claim 21 are wherein the SAMT-247 microbicide is administered within four hours of a potential HIV-1 exposure (claim 22); and wherein the SAMT-247 microbicide is administered in an intravaginal ring prior to an HIV-1 exposure (claim 23).
Claim Rejections - 35 USC § 112(a); First Paragraph
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 1-20 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.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice .... reduction to drawings .... or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1-23 are rejected as lacking adequate descriptive support for any method in any subject through delivery of any of the HIV-1 Env mutants in any of the claimed formats along with any SAMT-247 microbicide in any sequence which then results in the claimed functional outcome of inhibition of HIV acquisition.
In support of the claimed genera (any subject, any HIV-1 Env 137-152 mutants, any SAMT-247 microbicide), the application discloses specific V1-deleted recombinant gp120 proteins corresponding to HIV-1 Env circulating recombinant form AE strain A244, clade B strain MN, and clade C strain 96ZM651, set forth as SEQ ID NOs: 2-4 (¶[0123]). The specification further describes certain recombinant gp120 proteins having at least 90% identity to SEQ ID NOs: 2-4 while retaining the V1 deletion (¶[0130-0104][0121]).
The working examples start at ¶[0255] and detail a study in macaques, wherein vaccination with an SIV Env-delV1+alum was compared with and without the administration of SAMT-247. The study tested female macaques which were exposed intravaginally to SIV five weeks after the last SIV Env-delV1+alum vaccination (see Fig. 1 for dosing regimen); some were repeatedly exposed for up to 14 consecutive weeks, and some had received at least 4 hours prior to exposure a treatment with 0.8% SAMT-247 in HEC gel (although it is not clear how the gel was administered.)(¶[0255]). The dosing regimen noted in Fig. 1 shows that SIV gp160delV1 and SIV gag were administered at day 0 and week 4, followed by a viral vector boost (ALVAC) that delivered the SIV antigens env, gag, and pol (ALVAC-SIV) at week 8, followed by an additional ALVAC-SIVdelV1gp120/alum boost at weeks 12 and 13 (¶[0008]; Fig. 1). Vaccine alone decreased the risk of virus acquisition by 65% (p=0.0074; FIG. 1B), consistent with prior published data, while the vaccine+SAMT-247 combination afforded a 92.7% reduction in the risk of virus acquisition when compared to all controls (p=0.0001; FIG. 1C), as well as concurrent and historical controls separately (p=0.0002 and p=0.0001 respectively) and differed significantly from the vaccinated only group (p=0.006; FIG. 1C).
The scope of claim 1 is not limited to any particular HIV-1 strain, clade, subtype, amino acid sequence, sequence-identity threshold, or other structural feature of the recombinant gp120 protein apart from the recited deletion, and therefore encompasses a broad genus of structurally diverse recombinant gp120 proteins and nucleic acids encoding said protein. Likewise, the claims are drawn to “a SAMT-247 microbicide”, which, as per ¶[0099-0100][0181] of the specification note, include SAMT-247 and pharmaceutically acceptable salts, derivatives thereof, and prodrugs thereof. Therefore, the claims are not merely limited to only “SAMT-247”, but include a broader range of compositions because a SAMT-247 microbicide [emphasis added] is claimed. While claim 21 narrows the method further than claim 1, it still broadly claims the use of any DNA vector delivering the Env-V1 del mutant in the priming step, the use of any vector encoding any HIV env, gag, and pol in a booster step, any purified gp120 protein comprising the V1 deletion with any alum adjuvant in another booster step, and any intra-vaginal delivery of any SAMT-247 microbicide at any step in the method. This claim does not require the steps to happen in any particular order per se aside from the “priming” composition delivered before the noted “boosting” compositions.
The scope of the claims is not commensurate in scope with the methods actually performed. No derivatives, prodrugs, or salts of SAMT-247 were delivered, and it is not clear how said compound was delivered in the vaccination regimen (e.g. intravaginally, orally, subcutaneously, etc.). The methods utilized a specific heterologous prime/boost regimen, wherein the prime was with a gp160 that comprised a deletion in V1, followed by an ALVAC™ (canarypox) viral vector delivering full sequences of Env, Gag, and Pol, followed by two further boosts of the ALVAC™ vector delivering SIV gp120-delV1 adjuvanted with alum, followed by SAMT-247 administration in an unknown manner prior to viral challenge. No studies were done with homologous prime/boost systems, no other vectors were tested, no other adjuvants were tested, SAMT-247 and/or the vaccine delivered in different routes were not tested, no other vaccination timing events (e.g. concomitant administration of Env+SAMT-247; SAMT-247 delivery before Env delivery, etc.) were tested. Thus, the application fails to provide a sufficient number of examples of species within the broadly claimed genera.
Further, while the claims provide both a structure and a function, the application fails to draw any correlation between the two. For instance, there is no evidence that any SAMT-247 salt, derivative, or prodrug delivered in any form to any location on the subject can still retain the ability to boost the activity of the HIV Env V1 deletion mutant vaccination. Moreover, no correlation has been made to which specific Env strain, clade, subtype, or amino acid sequence should be used within the claims; the methods provided for in the examples either use gp160 or gp120 with the V1 deletion and an undisclosed Env as a booster protein; it is unclear how substitution with other sequences or delivery formats will affect the therapeutic outcome of the method.
Thus, in view of the above, there would have been significant uncertainty as to which Env mutants, which forms of SAMT-247, and which specific prime/boost vaccination regimens would be able confer the claimed HIV-1 protection. In view of this uncertainty and the lack of sufficient examples of the claimed genera, the claims are rejected for lack of adequate written description support.
Claims 1-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for specific vaccination regimens in specific patient populations delivering specific types and formulations of SIV/HIV Env with/without V1 deletions along with SAMT-247 microbicide to protect against SIV/HIV, does not reasonably provide enablement for any vaccination regimens in any subject delivering any Env mutants and any SAMT-247 salts, derivatives, or prodrugs thereof through any route to protect against any HIV challenge. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. The claims are drawn to methods of inhibiting HIV or HIV-1 acquisition by administering a V1-deleted HIV-1 Env immunogen, or a nucleic acid molecule encoding the same, together with a SAMT-247 microbicide.
Independent claim 1 broadly encompasses administering any recombinant gp120 protein comprising a deletion corresponding to HIV-1 Env residues 137-152 according to the HXBc2 numbering system, or any nucleic acid molecule encoding said recombinant gp120 protein, provided that said gp120 protein elicits an immune response to HIV-1. Claim 1 further requires an effective amount of “a” SAMT-247 microbicide, thereby inhibiting HIV-1 acquisition in the subject.
Independent claim 21 recites a more specific prime-boost regimen, but remains broad, as it encompasses any DNA vector encoding the recited Env V1 mutant, any vector encoding any HIV Env, HIV gag, and HIV pol, and any purified V1-deleted gp120 protein formulated with any alum-comprising adjuvant, together with intravaginal delivery of SAMT-247.
As set forth supra in the 35 USC 112a written description rejection, the gp120 protein is not limited to a particular strain, clade, subtype, sequence, sequence-identity threshold, nucleic acid sequence, expression platform, vaccination schedule, route of administration, type and/or formulation of SAMT-247, HIV exposure route, or subject population. The specification states that the subject can be male or female, and may be any subject at risk for contracting HIV-1 infection (¶[0107-0109][0206]). Claim 21 does not limit the types of vectors which may be used, the doses of any components, the timing intervals, formulations of compounds, or subject populations.
State of the prior art/Predictability of the art. At the time of filing, a person of ordinary skill in the art understood that prevention of HIV acquisition using vaccines, microbicides, or a combination thereof was an active and highly unpredictable area of investigation. The prior art disclosed individual components relevant to the presently claimed methods, but did not provide a general rule allowing a skilled artisan to predict which combinations of immunogen, vector, adjuvant, dosing regimen, formulation, route, subject population, and viral-exposure context would inhibit HIV acquisition.
For example, Franchini et. al. (WO2020086483A1; CITED ART OF RECORD; Pub. 04/30/2020) discloses recombinant gp120 proteins comprising a deletion of HIV-1 Env residues 137-152 according to the HBXc2 numbering system, including gp120 proteins comprising or consisting of HIV-1 Env residues 31-507 with the deletion, related gp160 and Env-trimer embodiments, nucleic acids encoding the disclosed immunogens, expression vectors, immunogenic compositions, adjuvants, and methods of eliciting an immune response that inhibits HIV-1 infection (entire document; see abstract; claims.) Franchini showed that while the Env delV1 vaccinated animals elicited increased protection against some SIV subtypes, there was increased risk of virus acquisition with other subtypes.
Inman et. al. (US20050020831A1, Pub. 01/27/2005) discloses acylthiol and component thiol compounds as anti-HIV agents (entire document; see abstract). Inman teaches that such compounds can inhibit viral infectivity or transmission through effects on nucleocapsid protein NCp7 (¶[0083-0088][0121]). Inman further teaches pharmaceutical formulations for mammalian administration, including oral, topical, transmucosal, vaginal, and rectal administration; topical ointments, creams, salves, powders, and gels; sustained-release delivery mechanisms; and vaccine formulations comprising inactivated virus or an isolated complex of a viral protein or peptide with a disclosed compound (¶[0131-0156][0161-0162]). Silva de Castro (Silva de Castro I, et. al. iScience. 2021 Jan 9;24(2):102047.) notes that deletion of the V1 loop from Env can expose conserved V2 loop epitopes and improve protective immune responses in a particular vaccine context, namely when said mutated Env is delivered via ALVAC™ vectors, but that the V1 deletions had to present the V2 loop in a specific conformation to be efficacious (p. 4, ¶3; p. 11, “Discussion”.)
Cheng-Mayer et. al. (Cheng-Mayer C, et. al. AIDS. 2011 Sep 24;25(15):1833-41.) describes a gag-pol fusion protein vaccine and SAMT-247 topical-microbicide regimen in macaques challenged with SHIV. The results supported continued investigation of combined prophylactic approaches, but did not establish that any vaccine and any form of SAMT-247 regimen would predictably inhibit acquisition across different viral strains, immunogens, challenge models, or administration conditions.
Helmold Hait et. al. (Helmold Hait S, et. al. J Immunol. 2020 Jun 15;204(12):3315-3328. Epub 2020 May 11.) evaluated SAMT-247 in an intravaginal SIV challenge macaque model. As reflected in the title of this paper and the abstract, the added vaccine component produced mixed outcomes. The reference does not establish that vaccine-microbicide efficacy is predictable across materially different vaccine constructs, routes, formulations, or subject populations. However, Helmold Hait provided motivation to further investigate the vaccine-microbicide strategy, and encouraged studying this vaccine strategy in human clinical trials (abstract.)
Vaccari et. al. (Vaccari M, et. al. Nat Med. 2016 Jul;22(7):762-70. Epub 2016 May 30.) provides a discussion of ALVAC-vectored HIV/SIV vaccines, and notes that there is uncertainty in the efficacy of such vaccines alone or in combination with other vaccine regimens in inhibition of HIV acquisition. Vaccari teaches that the protective effects of ALVAC-based vaccines requires empirical testing and is unpredictable, as the success of such platforms varies upon the selected adjuvant, vaccine regimen, and induced immune responses.
Accordingly, the prior art established that individual gp120 immunogens, nucleic acid vaccination platforms, SAMT-class compounds, topical microbicides, and vaccine-microbicide strategies were known, but that said platforms were still actively being investigated and showed unpredictable results in that protective efficacy was context-dependent and could not be reliably extrapolated across the full breadth of the presently claimed methods.
Working examples. The working example disclosed in the specification was discussed supra with the written description rejection. To summarize briefly, the working example involved a particular SIV macaque model that received DNA vectors encoding gp160-delV1 at weeks 0 and 4, ALVAC-vectored gag/pol/env at week 8, and ALVAC with purified gp120-delV1 protein and alum at weeks 12 and 13. Five weeks after the final vaccination, the animals were challenged intravaginally weekly and received 0.8% SAMT-247 formulated as a gel (it is unclear if this was delivered/administered intravaginally.)
The disclosed results show that this particular heterologous prime/boost vaccination regimen reduced the risk of acquiring SIV over the same vaccination without the SAMT-247. However, the working examples failed to test inhibition of HIV in humans, HIV/SIV acquisition in male subjects, inhibition of acquisition following exposure via other routes (e.g. rectal exposure), administration of SAMT-247 in any other manner in any other format (e.g. oral, subcutaneously, etc. via suppository, cream, pill, etc.), the efficacy of SAMT-247 salts, derivatives, or prodrugs, efficacy of any other type of nucleic acid delivery, such as RNA vaccination, efficacy of any other vector delivery, including any other non-ALVAC™ viral vector, or the testing of SAMT-247 delivered as an intravaginal ring. The results did not look at only a env/pol booster as recited in dependent claim 20, only a booster of gag/pol/env. No other HIV/SIV strains, clades, sequences, or nucleic acids were tested. Therefore, the example provides a working embodiment of a limited method for combined vaccination, but fails to support predictable HIV inhibition methods across the breadth of the claimed methods.
Guidance in the specification. The specification provides guidance towards specific embodiments, namely the use of the specific formulation of SAMT-247 at ¶[0099] delivered intravaginally prior to viral challenge and after a specific heterologous prime/boost vaccination regimen of a specific Env protein deleted for V1. The results in the specification highlight the unpredictability of even this method, as even this method remained suboptimal in the macaques, even with the addition of SAMT-247 gel, and while it increased protection over the vaccine alone, only 80% of the females tested were protected from infection and the risk of vaginal acquisition was increased from about 50% to 92.7% (¶[0270-0275]). With the limited example provided and the breadth of the limitations in the claims which still need to be tested, it remains that the general identification of possible embodiments does not provide sufficient guidance to practice the full scope of the claimed functional methods.
Amount of experimentation necessary. Additional research is required in order to determine which embodiments encompassed by the scope of claims 1-23 would be able to inhibit HIV acquisition as presently claimed.
In light of the Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) (hereafter Amgen), updated guidelines were provided regarding the assessment of enablement (Federal Register, pp. 1563-1566; Pub. Jan. 10, 2024.) In Amgen, the Supreme Court unanimously affirmed that a genus of monoclonal antibodies were not enabled because when a range within a genus is claimed, there must be reasonable enablement of the scope of the range. The Court found in Amgen that due to the large number of possible candidates within the scope of the claims and the specification's corresponding lack of structural guidance, it would have required undue experimentation to synthesize and screen each candidate to determine which compounds in the claimed class exhibited the claimed functionality. In the instantly claimed invention, a skilled artisan would need to select, construct, express, formulate, and evaluate numerous V1-deleted Env constructs (proteins and nucleic acid formats) from different HIV-1 strains and clades, and then further assess which vaccination regimens (e.g. timing, dose, heterologous/homologous prime/boost, delivery route, formulations, etc.) along with which alum-comprising adjuvants and which SAMT-247 derivatives would inhibit HIV acquisition from which strains and exposure routes in which subject populations, making the experimentation required to test the breadth of these limitations undue.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 and 9-22 are rejected under 35 U.S.C. 103 as being unpatentable over Franchini et. al. (WO2020086483A1; Pub. 04/30/2020; CITED ART OF RECORD; hereafter “Franchini”) in view of Helmold Hait et. al. (Helmold Hait S, et. al. J Immunol. 2020 Jun 15;204(12):3315-3328. Epub 2020 May 11.; hereafter “Helmold Hait”.)
The Prior Art
Franchini teaches recombinant HIV-1 gp120 proteins comprising a deletion of HIV-1 Env residues 137-152 according to the HXBc2 numbering system (entire document; see abstract; reference claim 1.) Franchini teaches that the recombinant gp120 protein elicit an immune response that inhibits HIV-1 infection in a subject (entire document; see abstract; ¶[0015]; reference claims 27-28.) Franchini teaches embodiments in which the recombinant gp120 protein comprise or consist of HIV-1 Env residues 31-507 containing the deletion of residues 137-152, according to the HXBc2 numbering system (reference claim 2; instant claim 2), and teaches SEQ ID NOs: 1-3, wherein reference SEQ ID NOs: 1 and 2 are 100% identical to instant SEQ ID NOs: 2 and 3, respectively (reference claim 3; instant claim 3). Franchini teaches the V1 deleted gp120 in pharmaceutical compositions which comprise pharmaceutically acceptable carriers (¶[0083]), wherein the compositions may be administered via oral, injection (such as subcutaneous, intramuscular, intradermal, intraperitoneal, and intravenous), sublingual, rectal, transdermal (for example, topical), intranasal, vaginal, and inhalation routes (¶[0039]). The compositions may comprise an adjuvant (¶[0081][0083]), such as an alum, Lipid-A, or QS21 (¶[0038][0100][0191]; instant claims 10-12). Franchini teaches nucleic acid molecules, such as RNA or DNA, or vectors encoding the gp120 or the precursor gp160 may be delivered in the immunogenic compositions (¶[0071][0083-0084][0118-0119][0170]; instant claims 13-17). Franchini teaches the subject may be a human subject, especially one at risk of having an HIV-1 infection (¶[0015][0108]). Franchini teaches that the composition may be administered in a prime/boost vaccination protocol, and the boosting immunogen can be different from the priming immunogen (¶[0060][0081][0097][0100]), wherein one of the compositions may be an ALVAC vector engineered to express HIV-1 gag and pro (¶[0100]; instant claim 20).
While Franchini teaches many aspects of the instant claims, Franchini is silent as to the delivery of SAMT-247 with V1-deleted gp120. However, motivation to deliver SAMT-247 with gp120 was present in the art, as taught by Helmold Hait.
Helmold Hait teaches a combined vaccine-microbicide strategy for inhibiting SIV/HIV acquisition (entire document; see abstract) Helmold Hait teaches vaccine groups were primed twice mucosally with replicating adenovirus type 5 host range mutant SIVenv/rev, gag, and nef recombinants and boosted twice intramuscularly with SIV gp120 proteins in alum, wherein those which received both the vaccine-microbicide regimen received SAMT-247 as the microbicide (abstract). Helmold Hait evaluates vaccine-only, vaccine-microbicide, microbicide only, and control groups of rhesus macaques, and teaches that following vaccination, macaques were challenged intravaginally with repeated weekly low doses of SIVmac251 administered 3 h after application of 0.8% SAMT-247 gel (abstract; instant claims 6-7, 19, 22). Helmold Hait teaches the vaccine–microbicide group exhibited significant acquisition delay compared with both control and vaccine-only groups, indicating further exploration of the combination strategy is warranted (abstract; Fig. 1).
It would have been obvious to a person of ordinary skill in the art to administer the SAMT-247 microbicide with the V1-deleted gp120 immunogens of Franchini, as Helmold Hait expressly provides a reason to combine a gp120-containing vaccine regimen with SAMT-247 microbicide administration to improve prophylaxis against HIV/SIV acquisition. Helmold Hait teaches that the different compositions are delivered via different routes, and Franchini teaches a number of routes in which compositions can be delivered, including orally and intravaginally. Given that Helmold Hait teaches the macaque study in female macaques, and delivery of the microbicide intravaginally, it would be obvious to also try and deliver the microbicide intravaginally to humans. Both Helmold Hait and Franchini teach heterologous prime/boost vaccination regimens, making the combination of different elements to stimulate different arms of the immune system obvious to a skilled artisan. The claims do not require synergy, a particular magnitude of acquisition-risk reduction, or superiority over administration of SAMT-247 alone, providing a skilled artisan with a reasonable expectation of success in delivering SAMT-247 with the gp120 mutant of Franchini. Given the teachings of Franchini and Helmold Hait, it would be obvious to arrive at the limitations of instant claims 1, 4-5, 9, 18, and 21.
It would have been obvious to one of ordinary skill in the art to modify the methods and compositions taught by Franchini in order to deliver the microbicide SAMT-247, thereby providing a reasonable expectation of success in improving the ability to inhibit HIV/SIV acquisition over the gp120 deletion mutant vaccine alone. One would have been motivated to do so, given the suggestion by Helmold Hait that co-administration of SAMT-247 with gp120 vaccines needed to be investigated further. There would have been a reasonable expectation of success, given the knowledge that Helmold Hait suggested combining a gp120-comprising vaccine with SAMT-247 and given that it would be reasonable to assume the gp120 vaccine of Franchini would retain its disclosed ability to elicit an immune response and that it would be reasonable to assume the SAMT-247 would retain its disclosed microbicidal activity when used in the combined prophylactic regimen. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 8 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Franchini and Helmold Hait as applied to claims 1-7 and 9-22 above, and further in view of Herrera et. al. (Herrera C, et. al. Curr Top Microbiol Immunol. 2014;383:1-25.; hereafter “Herrera”.)
The Prior Art
The teachings of Franchini and Helmold Hait have been set forth supra. While Franchini teaches that the compositions may be delivered in a variety of ways, including orally and intravaginally, Franchini fails to teach the use of vaginal ring delivery devices for any of the compositions. Similarly, while Helmold Hait teaches intravaginal delivery of the SAMT-247 microbicide, she is silent as to the delivery method being performed with an intravaginal ring. However, the use of such devices to deliver SAMT-247 microbicide was provided in the art, as evidenced by Herrera.
Herrera teaches the use of intravaginal rings for the sustained release delivery of microbicides (Sect. 2.2; p. 7, ¶2; p. 9, ¶4). Herrera teaches a class of microbicide agents are the S-acyl-2-mercaptobenzamide thioesters (SAMTs), of which SAMT-247 has shown promising results in cellular and tissular preclinical studies, with SAMT-247 showing activity against vaginal challenge when used topically in non-human primates (p. 9, ¶2.) Herrera also teaches about the use of pre-exposure oral prophylaxis (PrEP) and vaccines, and that it is being explored as to whether or not PrEP can be combined with microbicides, or the use of microbicides with candidate vaccines to provide a comprehensive prevention strategy (pp. 14-15, ¶ bridging pages.)
Given the related teachings of Franchini, Helmold Hait, and Herrera, it would be obvious to try different methodologies of delivery for the SAMT-247 microbicide, given that Franchini teaches different methodologies of delivering compounds to a subject. The use of sustained-release intravaginal rings would be obvious to try, given that Franchini, Helmold Hait, and Herrera all teach vaginal delivery of anti-HIV/SIV compositions, and especially since the SAMT-247 composition was noted to have intravaginal efficacy by both Helmold Hait and Herrera. Therefore, it would be obvious to a skilled artisan to arrive at the limitations of instant claims 8 and 23.
It would have been obvious to one of ordinary skill in the art to modify the methods and compositions taught by Franchini and Helmold Hait in order to deliver the microbicide SAMT-247 through a vaginal ring, thereby providing a sustained release format for the SAMT-247 microbicide. One would have been motivated to do so, given the suggestion by Herrera that SAMT-247 was known to work vaginally in the art against HIV, and given that Herrera suggests the delivery of microbicides either orally or through the use of vaginal rings. There would have been a reasonable expectation of success, given the knowledge that Herrera suggests the use of microbicides, such as SAMT-247, with vaccine formulations and PrEP prophylaxis. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,162,910 in view of Helmold Hait et. al. (Helmold Hait S, et. al. J Immunol. 2020 Jun 15;204(12):3315-3328. Epub 2020 May 11.; hereafter “Helmold Hait”); Inman et. al. (US20050020831A1; Pub. 01/27/2005; hereafter “Inman”); and Herrera et. al. (Herrera C, et. al. Curr Top Microbiol Immunol. 2014;383:1-25.; hereafter “Herrera”.)
Both the instant claims and the reference ‘910 claims are drawn to recombinant gp120 protein comprising a deletion consisting of deletion of HIV-1 Env residues 137-152 according to the HXBc2 numbering system. Instant SEQ ID NO: 3 and reference SEQ ID NO: 2 are 100% identical. Both claim that the gp120 protein comprises or consists of HIV-1 Env residues 31-507 with the deletion of residues 137-152. Both claim the mutated Env protein elicits an immune response to HIV-1. Both claim compositions comprising the mutated Env in a pharmaceutically acceptable carrier, along with an adjuvant. Both claim methods of eliciting an immune response against HIV-1 in a subject to treat or inhibit HIV-1 infection. The main differences between the two sets of claims is the formation of Env trimers is not recited in the instant claims, and the ‘910 claims are silent as to the additional use of SAMT-247 microbicide and other limitations specific to the delivery of the compositions. However, such differences would be obvious in light of the prior art, as evidenced by Helmold Hait, Inman, and Herrera. Helmold Hait teaches the administration of SAMT-247 as a gel as an additional microbicide in a vaccine-microbicide prophylaxis strategy. Helmold Hait (see discussion supra) teaches administration of SAMT-247 intravaginally to female rhesus macaques as a 0.8% gel three hours before intravaginal viral challenge, and delivery of the vaccine with alum as an adjuvant intramuscularly. Inman teaches the SAMT-based compositions, including SAMT-247, and teaches vaginal, oral, and rectal administration of the formulations as suppositories, creams, and gels. Inman also teaches the sustained-release delivery of these SAMT compounds. Herrera (see discussion supra) teaches HIV Env form trimers of non-covalently linked heterodimers of gp120 and gp41, and teaches the use of intravaginal rings or oral delivery of microbicides to treat HIV infection, including SAMT-247. Therefore, modifying the ‘910 claims to arrive at the instant claims would be obvious to a skilled artisan, especially in light of the teachings of Helmold Hait, Inman, and Herrera, and the claims are not patentably distinct.
Claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 18/970,709 in view of Helmold Hait et. al. (Helmold Hait S, et. al. J Immunol. 2020 Jun 15;204(12):3315-3328. Epub 2020 May 11.; hereafter “Helmold Hait”); Inman et. al. (US20050020831A1; Pub. 01/27/2005; hereafter “Inman”); Franchini et. al. (WO2020086483A1; Pub. 04/30/2020; CITED ART OF RECORD; hereafter “Franchini”); and Herrera et. al. (Herrera C, et. al. Curr Top Microbiol Immunol. 2014;383:1-25.; hereafter “Herrera”.)
Both the instant claims and the reference ‘709 claims are drawn to recombinant gp120 protein comprising a deletion consisting of deletion of HIV-1 Env residues 137-152 according to the HXBc2 numbering system. Instant SEQ ID NO: 3 and reference SEQ ID NO: 2 are 100% identical. Both claim that the gp120 protein comprises or consists of HIV-1 Env residues 31-507 with the deletion of residues 137-152. Both claim the mutated Env protein elicits an immune response to HIV-1. Both claim compositions comprising the mutated Env in a pharmaceutically acceptable carrier, along with an adjuvant. Both claim methods of eliciting an immune response against HIV-1 in a subject to treat or inhibit HIV-1 infection. The main differences between the two sets of claims is the formation of Env trimers or the use of canarypox vectors is not recited in the instant claims, and the ‘709 claims are silent as to the additional use of SAMT-247 microbicide and other limitations specific to the delivery of the compositions. However, such differences would be obvious in light of the prior art, as evidenced by Helmold Hait, Inman, Franchini, and Herrera. Helmold Hait (see discussion supra) teaches the administration of SAMT-247 as a gel as an additional microbicide in a vaccine-microbicide prophylaxis strategy. Helmold Hait teaches administration of SAMT-247 intravaginally to female rhesus macaques as a 0.8% gel three hours before intravaginal viral challenge, and delivery of the vaccine with alum as an adjuvant intramuscularly. Inman teaches the SAMT-based compositions, including SAMT-247, and teaches vaginal, oral, and rectal administration of the formulations as suppositories, creams, and gels. Inman also teaches the sustained-release delivery of these SAMT compounds. Franchini (see discussion supra) teaches the delivery of gp120 V1-deleted mutants using canarypox virus-based vectors (ALVAC™). Herrera (see discussion supra) teaches HIV Env form trimers of non-covalently linked heterodimers of gp120 and gp41, and teaches the use of intravaginal rings or oral delivery of microbicides to treat HIV infection, including SAMT-247. Therefore, modifying the ‘709 claims to arrive at the instant claims would be obvious to a skilled artisan, especially in light of the teachings of Helmold Hait, Inman, Franchini, and Herrera, and the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and is listed below.
US20140220060A1. Teaches V1 loop deleted Env constructs. Not utilized as rejection would be redundant to those set forth supra.
US20190085033A1. Teaches V1 loop deleted Env constructs. Not utilized as rejection would be redundant to those set forth supra.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN can be reached on 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RACHEL B GILL/
Primary Examiner, Art Unit 1671
Prosecution Insights