DETAILED ACTION
Disposition of Claims
Claims 1-29, 31, and 33 were pending. Claims 1-35 have been cancelled. New claims 36-53 are acknowledged and entered, and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230063876A1, Published 03/02/2023. Amendments to the specification presented on 11/24/2025 are acknowledged and entered.
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.
The Power of Attorney filed 07/25/2025 is acknowledged and entered.
Response to Arguments
Applicant's arguments filed 11/24/2025 regarding the previous Office action dated 07/23/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Optional Authorization to Initiate Electronic Communications
The internet communications authorization filed on 07/28/2025 is acknowledged and entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
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).
The drawings are objected to because of the reference to color in the drawings with the submission of black and white drawings (See e.g. ¶[0026] for Fig. 1 legend in specification, also ¶[0027-0028] Figs. 2-3.) 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.
It is noted that a petition was filed on 11/24/2025 to accept color drawings, which was denied on 12/11/2025. A subsequent petition was filed on 01/14/2026 and is under review as of the writing of this Office action.
Claim Objections
(Objection withdrawn.) The objection to Claim 6 is withdrawn in light of the cancellation of claim 6.
(Objection withdrawn.) The objection to Claim 12 is withdrawn in light of the cancellation of claim 12.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 2 and 7-8 and dependent claims 9-29, 31, and 33 thereof under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of said claims.
(Rejection withdrawn.) The rejection of Claim 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of said claim.
(New rejection – necessitated by amendment.) Claim 38 and dependent claims 40, 42, 44, 46, 48-49, 51, and 53 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.
The term “neutral amino acid residues” in claim 38 is a relative term which renders the claim indefinite. The term “neutral amino acid residues” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification at ¶[0015] notes what these may be in certain embodiments, it is not clear that these are the only “neutral” amino acids, as the specific pH of the composition has not been claimed, and the charge on an amino acid can change depending on the physiological conditions said amino acid is under. For instance, at pH 7, most amino acids are neutral, and include Alanine (Ala), Valine (Val), Leucine (Leu), Isoleucine (Ile), Proline (Pro), Phenylalanine (Phe), Tryptophan (Trp), Methionine (Met), Glycine (Gly), Serine (Ser), Threonine (Thr), Cysteine (Cys), Asparagine (Asn), Glutamine (Gln), and Tyrosine (Tyr). As Histidine (His) has a pKa of about 6.0, it will have a positive charge around pH 5.5, and at a pH of 8.0 a net charge of 0; at a physiological pH of about 7.0, His may have a slightly positive charge. Therefore, as the pH of the composition has not been claimed, and the amino acids have not been specifically delineated in the claim as to which ones are considered “neutral”, the claim is rejected on the grounds of being indefinite.
Claim 40 is included in this rejection as it is dependent upon claim 38, and is drawn to a linker which “comprises” 4 glycine and a cysteinyl residue, and as the oligomer may be 6 amino acids long, it is unclear as to the additional unrecited elements and their charge.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 38 is rejected on the grounds of being indefinite. Claims 40, 42, 44, 46, 48-49, 51, and 53 are also rejected since they depend from claim 38, but do not remedy these deficiencies of claim 38.
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 36 is drawn to a composition for inhibiting, treating or preventing a fentanyl induced disorder of respiratory depression or a slow breathing rate in a patient or subject caused by a fentanyl overdose in said patient or subject, wherein said composition is comprising:
(a) a virus-like particle (VLP) comprising a Qbeta bacteriophage monomer coat protein; and
(b) at least one opioid molecule covalently linked to the surface of the VLP through a linker group thereto;
wherein said opioid molecule is fentanyl and said opioid molecule is displayed on the surface of said virus-like particle by covalently linking said opioid molecule to one or more lysine residues on the surface of said virus-like particle through said linker group, wherein said linker group comprises an oligopeptide of from 4 to 6 mer covalently linked to said opioid molecule on one end and to a crosslinker molecule on the other end, and wherein the crosslinker molecule is covalently linked to said lysine residue(s) on the surface of said VLP.
MPEP § 2111.02 (II) recites, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the pre-amble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limita-tions, then the preamble is not considered a limitation and is of no significance to claim construction.” Presently, the recitation of “for inhibiting, treating or preventing a fentanyl induced disorder of respiratory depression or a slow breathing rate in a patient or subject caused by a fentanyl overdose in said patient or subject” in claim 36 is interpreted as intended use and therefore, will not be read as a limitation into the claimed invention.
Further limitations on the composition of claim 36 are wherein said oligopeptide is covalently bonded to said fentanyl molecule and the crosslinker molecule is linked to said lysine residue(s) on the surface of said bacteriophage (claim 37); wherein said oligopeptide comprising neutral amino acid residues (claim 38), wherein said neutral amino acid residues are glycine residues (claim 39), wherein said oligopeptide comprises 4 glycine amino acid residues and a cysteinyl residue, wherein said oligopeptide covalently bonds to said crosslinker molecule through said cysteinyl residue (claim 40), wherein said crosslinker molecule is succinimidyl 6-((beta-maleimidopropionamido)hexanoate) (SMPH)(claims 40, 41); comprising a population of said virus-like particles (claims 43-44).
A pharmaceutical composition comprising a population of virus-like particles according to claim 36 (claim 45) or claim 42 (claim 46) in combination with a pharmaceutically acceptable carrier, additive and/or excipient.
Further limitations on the composition according to claim 45 or claim 46 is wherein the composition is formulated as a vaccine for administration to a subject or patient (claim 47, 48); and wherein said vaccine comprises an adjuvant (claim 49).
A method for inhibiting, treating or preventing a fentanyl induced disorder caused by fentanyl overdose in a patient or subject in need thereof comprising introducing the composition of claim 43 (claim 50) or claim 44 (claim 51) into said subject or patient, wherein an enhanced immune response against said fentanyl is produced in said patient or subject.
Further limitations on the method of claim 50 or claim 51 are wherein the fentanyl use disorder is respiratory depression or a slow breathing rate (claims 52-53).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection maintained in part and extended – necessitated by amendment.) Claims 36-39, 41, 43, 45, 47, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bachmann et. al. (US20130142821A1; Pub. 02/27/2013; hereafter “Bachmann”.) Note that this rejection is withdrawn with respect to cancelled claims 1-10, 15-29, 31, and 33 and is extended to include new claims 36-39, 41, 43, 45, 47, and 50.
The Prior Art
Bachmann teaches a conjugate of a hapten with a carrier in an ordered and repetitive array, and methods of making such compositions, wherein the conjugates and compositions comprise a variety of haptens, including hormones, toxins and drugs, especially drugs of addiction (entire document; see abstract.) Bachmann teaches the haptens are attached to core particles, such as virus-like particles (VLPs) from bacteriophages (¶[0019-0022]), wherein the VLPs comprise coat proteins from bacteriophages, such as AP205 coat protein or Qβ capsid protein (¶[0216][0333]). Bachmann teaches that the drugs of addiction include opioids and morphine derivatives, such as codeine, fentanyl, heroin, morphium and opium (¶[0232]).
While Bachmann teaches attachment of the antigen to a cysteine residue on one side and a lysine residue on the other may lead to random orientation on the particles (¶[0189]), Bachmann also teaches insertion of additional lysine residues on the Qbeta VLP surface which leads to higher density arrays of the antigen exposure (¶[0191]). Bachmann teaches the antigens may be joined via a covalent or non-covalent bond and can utilize a linker, that the antigens may be crosslinked to the VLP (¶[0019-0021][0051-0052][0077][0083][0157][0212-0214][0237]), and that flexible linkers are favored (¶[0212]). Bachmann teaches the preferred attachment site to the core VLP is through a lysine, arginine, cysteine, aspartate, glutamate, tyrosine or histidine amino acid (¶[0020]; claim 37), and that one way of linkage is through a polypeptide linker with linking a lysine residue on the VLP to a cysteine reside on the polypeptide linker (¶[0214]). Bachmann teaches SEQ ID NO: 11, which is a GGKGG linker (claims 38-39). Bachmann teaches that the opioid which may be conjugated to the VLP includes fentanyl (¶[0232]). Bachmann therefore teaches every aspect of the composition of instant claim 36.
Per MPEP 2111.02 Effect of Preamble: I. Preamble Statements Limiting Structure
“Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation.”
However, the recitation of "for inhibiting, treating or preventing a fentanyl induced disorder of respiratory depression or a slow breathing rate in a patient or subject caused by a fentanyl overdose in said patient or subject" does not impart any structure to the claimed invention because it does not establish how the function of “inhibiting, treating or preventing a fentanyl induced disorder of respiratory depression or a slow breathing rate in a patient or subject caused by a fentanyl overdose in said patient or subject” alters the virus-like particle (VLP) comprising a Qbeta bacteriophage monomer coat protein conjugated to fentanyl through a linking group resulting in it being different than the Qbeta VLP conjugated to fentanyl as outlined in Bachmann.
Even in arguendo if the preamble limitations were considered in regards to claim 36, the recitation of “for inhibiting, treating or preventing a fentanyl induced disorder of respiratory depression or a slow breathing rate in a patient or subject caused by a fentanyl overdose in said patient or subject” is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138 (CCPA 1946); In re Swinehart, 169 USPQ 226 (CCPA 1971); and In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). A patent applicant is free to recite features of an apparatus either structurally or functionally. See In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 228 (CCPA 1971) (“ [T]here is nothing intrinsically wrong with [defining something by what it does rather than what it is] in drafting patent claims.”). Yet, choosing to define an element functionally, i.e., by what it does, carries with it a risk. As our predecessor court stated in In re Swinehart, 439 F.2d at 213, 169 USPQ at 228:
where the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on
Therefore, the feature of “for inhibiting, treating or preventing a fentanyl induced disorder of respiratory depression or a slow breathing rate in a patient or subject caused by a fentanyl overdose in said patient or subject“ would be an inherent characteristic of the VLPs of Bachmann since the VLPs of Bachmann meet all the structural limitations of the claimed composition.
Bachmann teaches the hapten may be conjugated to the VLP through an active group, such as a vinyl, amine, or hydroxyl group (reference claim 42), and can utilize cross-linking molecules such as SMPH (¶[0216][0223]; instant claim 41). Bachmann teaches the VLPs may be within pharmaceutical compositions, such as vaccine compositions, that comprise further pharmaceutically acceptable salts, buffers, adjuvants, excipients, and/or carriers (¶[0025-0026][0030][0265][0269-0270]; instant claims 43, 45, 47). Bachmann teaches that the compositions are useful for treating addiction, facilitating withdrawal symptoms (antinociception), treating poisoning (overdose), treating intoxication, and for generally raising an immune response against the hapten attached to the VLP in order to treat or prevent disorders associated with the hapten, such as an opioid, attached to the VLP (¶[0025-0030][0232][0273][0276]; instant claim 50).
For at least these reasons, Bachmann teaches the limitations of instant claims 36-39, 41, 43, 45, 47, and 50, and anticipates the invention encompassed by said claims.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not entirely persuasive. While the rejection has been withdrawn with respect to all previously pending claims in light of the cancellation of said claims, the teachings of Bachmann are still relevant to the new claims for the reasons set forth supra.
Applicant argues that Bachmann does not provide any specific teaching of generation of a VLP conjugated to fentanyl, and instead fentanyl is to be selected from a number of different opioid drugs listed. Bachmann teaches the VLP of the instant claims, in that it is a Qbeta bacteriophage monomer coat protein VLP, and teaches that said VLP may be conjugated through linkers to a payload on its outer surface, and lists opioid drugs, including fentanyl, as a potential payload. Bachmann also teaches short linkers with glycine residues. Therefore, Bachmann teaches every aspect of the VLP of instant claim 36, and as per MPEP §2131.02.III, a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be “at once envisaged” from the disclosure. As Bachmann provides the structural elements for the VLP and notes which items may be conjugated to said VLP from a Markush grouping, one could at once envisage the instantly claimed VLP from the teachings of Bachmann. Additionally, as per MPEP §2131.02.II, a reference that clearly names the claimed species anticipates the claim no matter how many other species are named. Therefore, such an argument is not persuasive.
Applicant also argues that Bachmann fails to show evidence of inhibiting, treating, or preventing the fentanyl-induced disorders as presently claimed. As this is an anticipation rejection, as set forth supra, the intended use of the composition is not patentably relevant. Even if it was, as Bachmann teaches every element of the VLP-fentanyl conjugate as presently claimed, it would inherently possess the same functions as those of the instant claims. As Bachmann teaches the use of said VLPs to treat disorders arising from drug addiction, such as fentanyl use, Bachmann teaches the elements of the specific methods as noted supra. Bachmann teaches the immune response elicited would be suitable for the vaccine treatments, and such an immune response is not only enhanced by conjugation to the VLP, but can be further enhanced through the use of adjuvants (¶[0013][0040][0066][0148][0233]). Therefore, this line of argument is not persuasive.
For at least these reasons, Bachmann still anticipates the invention as presently claimed, and the rejection has been maintained.
(Rejection withdrawn.) The rejection of Claims 1-14, 16-29, and 31 under 35 U.S.C. 102(a)(1) as being anticipated by Bachmann et. al. (US20100092508A1, Pub. 04/15/2010; hereafter “Bachmann-2010”) is withdrawn in light of the cancellation of said claims.
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.
(New rejection – necessitated by amendment.) Claims 40, 42, 44, 46, 48-49, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann as applied to claims 36-39, 41, 43, 45, 47, and 50 above, and further in view of Bachmann et. al. (US20100092508A1, Pub. 04/15/2010; CITED ART OF RECORD; hereafter “Bachmann-2010”.)
The Prior Art
The teachings of Bachmann have been set forth supra. While Bachmann teaches the majority of the instantly claimed invention, and teaches the fentanyl may be linked to the VLP using a flexible amino acid linker of about 5 amino acids in length, and that said linker may comprise 4 glycines and the fentanyl may be linked through a cysteine residue, Bachmann is silent as to a specific linker sequence which comprises 4 glycine amino acids and a cysteine residue. However, such differences were known in the art for linker sequences, as evidenced by Bachmann-2010.
Bachmann-2010 teaches an AP205 virus like particle (VLP) with an antigen attached, and methods of making such compositions, wherein the conjugates and compositions comprise a variety of antigens, including antigens from infectious diseases, allergies, cancer, poisoning, and drugs, especially drugs of addiction (entire document; see abstract.) Bachmann-2010 teaches the antigens are attached to virus-like particles (VLPs) from bacteriophages (reference claim 13; ¶[0011-0013]), wherein the VLPs comprise coat proteins from bacteriophages (¶[0086-0096]). Bachmann-2010 teaches that the drugs of addiction include opioids and morphine derivatives, such as codeine, fentanyl, heroin, morphium and opium (¶[0106]). Bachmann-2010 teaches QBeta VLPs can comprise antigens on their surface, but focuses on the production of AP205 VLPs (Fig. 2; ¶[0292][0383]).
Bachmann-2010 teaches that the antigens that can be attached can be selected from opioids and morphine derivatives such as codeine, fentanyl, heroin, morphium and opium; relaxants such as diazepam; stimulants such as amphetamine, cocaine, MDMA (methylenedioxymethamphetamine), methamphetamine, methylphenidate and nicotine; hallucinogens such as LSD, mescaline and psilocybin; cannabinoids such as hashish and marijuana, other addictive drugs or compounds; and derivatives, by-products, variants and complexes of such compounds (¶[0106]). Bachmann teaches the compositions may be within pharmaceutical compositions, such as vaccine compositions, that comprise further pharmaceutically acceptable salts, buffers, adjuvants, excipients, and/or carriers (¶[0025-0028]). Bachmann-2010 teaches that the compositions are useful for treating addiction, treating poisoning (overdose), and for generally raising an immune response against the antigen attached to the VLP in order to treat or prevent disorders associated with the antigen, such as an opioid, attached to the VLP (abstract; reference claims 55-56; ¶[0027][0054][0104-0106]).
Bachmann-2010 teaches attachment of the antigen to a lysine residue through a cross-linker (¶[0007][0231]) at a reactive amine or carboxyl group (¶[0238-0240]) or through a peptide linker (¶[0232]), such as an amino acid linker (¶[0233]), including flexible serine/glycine linkers of sequence (GGGGS)n or glycine linkers ((G)n) (¶[0233]) or any of the linkers listed at ¶[0234-0235]) (SEQ ID NOs: 49-57), such as SEQ ID NOs: 54 and 55, which are GCGGGG and GGGGCG, respectively. As instant claims 36 and 40 notes the oligopeptide may be anywhere from 4-6 amino acids long, and would “comprise” 4 glycine amino acids and a cysteinyl residue, this allows for the addition of unrecited elements.
Given the related and combined teachings of Bachmann and Bachmann-2010, a skilled artisan would be apprised as to the generation of bacteriophage VLPs comprising fentanyl conjugated to the surface of said VLPs through amino acid linkers which are about 5mers in length and comprise glycine residues. Given the teachings of Bachmann-2010, a skilled artisan would be apprised as to linkers which comprised cysteine residues to aid in the attachment of the fentanyl. Therefore, given the combined teachings of Bachmann and Bachmann-2010, it would be obvious to arrive at the limitations of instant claims 40, 42, 44, 46, 48-49, and 51.
It would have been obvious to one of ordinary skill in the art to modify the methods and compositions taught by Bachmann in order to use linkers comprising at least 4 glycines and one cysteine in the linker, thereby adding a second attachment site between the VLP and opioid. One would have been motivated to do so, given the suggestion by Bachmann-2010 that the linker sequence would provide an additional attachment site through the use of a cysteine residue. There would have been a reasonable expectation of success, given the knowledge that such linkers allowed attachment of drugs to bacteriophage VLPs, as taught by Bachmann-2010. 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.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not entirely persuasive. While the 35 USC 102 rejection over Bachmann-2010 has been withdrawn with respect to all previously pending claims in light of the cancellation of said claims, the teachings of Bachmann-2010 are still relevant to render obvious elements of the new claims for the reasons set forth supra.
Applicant argues that neither Bachmann nor Bachmann-2010 anticipate or render obvious the instant claims. While said argument was persuasive with respect to Bachmann-2010 failing to anticipate the newly presented claims, Bachmann still anticipates for the reasons elaborated upon supra and Bachmann-2010 provides further elements to render obvious other aspects of the instant claims.
Applicant argues that since the Bachmann teachings fail to show delivery of fentanyl using the VLP platform, and since the instantly claimed compositions and methods provide high titers of antibodies and provide effective levels of immunogenicity after administration of only one or two doses, that neither Bachmann reference alone or in combination would render obvious the instant claims. First, given the guidance from the anticipatory teachings of Bachmann in further view of Bachmann-2010, one of skill in the art would have a reasonable (not absolute) expectation of success in generating a therapeutic immune response with the VLP platform if switching out the conjugated drug that was tested for another drug disclosed by either Bachmann reference. Namely, a skilled artisan would have a reasonable expectation of success in switching out nicotine or cocaine for fentanyl in the VLP, especially using the linker of Bachmann-2010, and arriving at a composition that would perform the therapeutic method as claimed. Further, any argument of surprising and/or unexpected results is not commensurate in scope with the present claims, as those specific conditions which provided said unexpected/surprising results are not in the present claim construction (e.g. specific linker used, specific Qbeta protein sequence, where and how the fentanyl is conjugated, dosage of VLP-fentanyl, delivery route, etc.) Therefore, this line of argument is not persuasive.
While Bachmann-2010 fails to anticipate the instant claims, his teachings are still relevant to rendering obvious certain aspects of the claims for the reasons set forth supra.
(New rejection – necessitated by amendment.) Claims 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann and Bachmann-2010 as applied to claims 36-51 above, and further in view of Pravetoni et. al. (US20220409722A1, Priority 11/08/2019; hereafter “Pravetoni”.)
The Prior Art
The teachings of Bachmann and Bachmann-2010 have been set forth supra. While both Bachmann and Bachmann-2010 teach the generation of bacteriophage VLPs conjugated to fentanyl on their outer surfaces, and teach the use of said VLPs in methods of treatment against opioid-related disorders, neither Bachmann reference specifically teaches the use of said VLPs for the treatment of fentanyl use disorders such as bradypnea (slow breathing rate) and/or hypoventilation (respiratory depression). However, the treatment of such conditions as a symptom of fentanyl use was known in the art, as evidenced by Pravetoni.
Pravetoni teaches compositions and methods for attenuating opioid induced respiratory depression through the use of fentanyl-hapten-carrier conjugate vaccine compositions (entire document; see abstract.) Pravetoni teaches the composition had a direct effect on fentanyl-induced respiratory depression in the animal model (Fig. 4; ¶[0028]; Fig. 9, ¶[0033][0048-0049]).
Given the teachings of Bachmann and Bachmann-2010, one of skill in the art would be apprised as to the usefulness of the VLP-fentanyl conjugates to treat or prevent the effects of fentanyl use disorders. Given the teachings of Pravetoni, one of skill in the art would be apprised as to one of the common symptoms of fentanyl use, namely respiratory depression. A skilled artisan, taking what was known in the art at the time of filing as evidenced by the teachings of Bachmann, Bachmann-2010, and Pravetoni, would find arriving at the limitations of instant claims 52-53 obvious.
It would have been obvious to one of ordinary skill in the art to modify the methods and compositions taught by the Bachmann references in order to use such VLP-fentanyl compositions in methods to therapeutically and/or prophylactically treat the symptoms of fentanyl use. One would have been motivated to do so, given the suggestion by Pravetoni that vaccines could be a more effective way to counteract the effects of fentanyl and prevent respiratory depression. There would have been a reasonable expectation of success, given the knowledge that fentanyl conjugates delivered in an animal model showed effects on inhibiting respiratory depression, as taught by Pravetoni. 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.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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