DETAILED ACTION
Disposition of Claims
Claims 1-20 are pending.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230398206A1, Published 12/14/2023.
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Claim Objections
Claim 1 is objected to because of the following informalities: the definition of the abbreviation “SARS-CoV-2” is not provided. For clarity, it is requested that the first recitation of an abbreviation within a claim set be preceded by its full-length name (i.e. … severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2)...).
Appropriate correction is required.
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 pre-AIA 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 1-20 are rejected as lacking adequate descriptive support for generating any severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2) spike (S) protein immunogenic fragment composition which results in the claimed function of generating any immune response in any human subject with when delivered intradermally.
In support of the claimed genera (any SARS CoV-2 S protein fragments, any human subject, any type of immune response), the application discloses one example in which human subjects are delivered through intradermal injection a DNP-modified or unmodified (adding the hapten 2,4-dinitrophenol (DNP) to peptide) vaccine containing SARS-CoV-2 S protein mixed with BCG (Bacillus Calmette-Guerin tuberculosis (TB) vaccine) (Example 1 at ¶[0068]) and also exhibits a skin reaction. It appears as though the S protein delivered was full-length S protein of SEQ ID NO: 2 (¶[0017][0022]), but this was not detailed in Example 1, nor was it detailed the exact sequence of the DNP hapten or the BCG composition. No derivatives or variants or mutants thereof are disclosed that can achieve this immune response, and it does not appear as though the SARS CoV-2 S protein or any fragments or derivatives thereof were delivered without the BCG vaccine to test for whether or not an immune response that could be detected through any skin and/or systemic immune response. It is not clear as to the type of human subjects that were tested (e.g. those that had a known exposure to TB, those that had a known exposure to SARS CoV-2, healthy subjects, age of subjects, sex of subjects, etc.) The intradermal delivery was via an insulin syringe and intradermal injection; it is not clear if other modalities of intradermal delivery (e.g. methods of delivery aside from the Mantoux method, such as microneedle patches, jet injectors, gene guns, or adapted tattoo devices) would result in eliciting the desired immune response. Thus, the application fails to provide examples of a sufficient number of species within the claimed genera.
Further, while the claims provide both a structure and a function, the application fails to draw any correlation between the two. In other words, there is no evidence that any SARS CoV-2 S protein or fragment thereof can be delivered intradermally and elicit any type of immune response in any human subject. Moreover, no correlation has been made as to which sequences, excipients, carriers, conjugations, and/or additional vaccine components are required in the immunogenic composition in order to achieve the claimed immune response in the breadth of any human subject. Lastly, the specification does not establish any additional testing of the SARS CoV-2 S protein compositions aside from the singular example noted supra, and even that example is insufficient to show what is, and what is not, required to elicit the claimed function.
Thus, in view of the above, there would have been significant uncertainty as to which SARS CoV-2 S proteins and fragments thereof would be able confer the claimed function of eliciting any immune response in any human subject when delivered through any intradermal means. 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.
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 2 and 4 and dependent claims 3 and 5-7 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 2 and 4 recite the limitation "at the site of injection" (claim 2, line 2; claim 4, lines 3-4.) There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the limitation will be interpreted as reading upon “at the site of administration”, but the claims must be amended for clarity.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant claims 2 and 4 are rejected on the grounds of being indefinite. Claims 3 and 5-7 are also rejected since they depend from claim 2 or 4, but do not remedy these deficiencies of claim 2 or 4.
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 eliciting an immune response in a human subject showing no signs or symptoms of an active severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) infection comprising administering intra-dermally to the human subject an immunogenic composition comprising the Spike protein (S protein) of SARS-CoV-2 or a fragment thereof.
Further limitations on the method according to claim 1 are wherein the method is further comprising measuring the magnitude of induration and erythema in the skin at the site of administration (claim 2), wherein the magnitude of induration is measured between twenty four (24) to seventy-two (72) hours after administration of the immunogenic composition (claim 3), wherein the magnitude of the induration in the skin is measured by using a software tool executed by a hardware processor of a computer device, wherein the computer device is configured to acquire at least one image of the skin at the site of administration (claim 4), wherein the computer device is a mobile device (claim 5), wherein the at least one image is analyzed at least in part by the hardware processor to automatically generate at least one indicator of a plurality of indicators each representing a respective probability of the human subject having SARS-CoV-2 infection, having had exposure to SARS-CoV-2, or having been vaccinated against SARS-CoV-2 (claim 6), wherein the plurality of indicators comprise a plurality of scores (claim 7); wherein the fragment thereof is the S1 (claim 8) or S2 (claim 9) subunit, or the receptor binding domain (RBD)(claim 10) of the S protein, wherein the S1 subunit comprises amino acids 17-680 of SEQ ID NO: 2 (claim 12), wherein the S2 subunit comprises amino acids 727-1195 of SEQ ID NO: 2 (claim 13), wherein the receptor binding domain comprises amino acids 417-560 of SEQ ID NO:2 (claim 14); wherein the S protein comprises SEQ ID NO: 2 (claim 11); wherein the S protein or fragment thereof is administered as a fusion protein (claim 15); wherein the S protein or fragment thereof is conjugated to a hapten (claim 16); wherein the immunogenic composition comprises at least one excipient (claim 17), wherein the at least one excipient comprises phosphate buffered saline (PBS) with 0.01% Polysorbate-20 and 0.5% phenol (claim 18); wherein the S protein or fragment thereof is present in an amount of 5-50 ug/mL (claim 19); and wherein the immunogenic composition comprises one or more additional SARS-CoV-2 proteins selected from the group consisting of M protein, N protein and E protein (claim 20).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-17, and 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rauch et. al. (US20240277830A1, Priority 02/04/2020; hereafter “Rauch”.)
The Prior Art
Rauch teaches delivery of SARS CoV-2 S protein immunogenic compositions to a healthy human subject for purposes of prophylactic vaccination (¶[0009][0059-0060][1090-1187][1668]), wherein the injection may be an intradermal injection/inoculation (¶[0089][0707-0708][0721-0722][0805][0810][1961]; instant claim 1). Rauch teaches monitoring the inoculation site for adverse events, such as redness of a certain size/diameter, swelling, itching, and pain (Table A; ¶[1187][1159][2459]; instant claim 2), wherein the subject has to remain on site for at least 30 minutes following inoculation for monitoring and then has a follow-up about 1-2 days after their first inoculation (¶[2077-2078]; instant claim 3).
Rauch teaches SEQ ID NO: 3 for S protein, which aligns with 100% identity to instant SEQ ID NO:2 (see ABSS alignments for 17/276,788). As Rauch teaches the SARS CoV-2 immunogen in the immunogenic composition may be full length S protein or fragments thereof, namely S1, S2, or the receptor binding domain (RBD) of S protein, Rauch therefore teaches the limitations of instant claims 8-14 (¶[0095][0241-0256]).
“Fusion protein” of instant claim 15 is broadly defined, and the spike protein itself as a full-length protein acts as a fusion protein that fuses with the target cell membrane (¶[0095]); therefore, delivery of full-length S protein is delivery of the S protein as a “fusion protein” under at least one reasonable interpretation of instant claim 15. Additionally, Rauch teaches the S protein may be fused to a heterologous protein to generate another type of “fusion protein” (¶[0322][0335]; instant claim 15). Rauch teaches that the S protein may be bound to a polymetric carrier, such as polyethylene glycol (PEG), which is a synthetic polymer that acts as a hapten when conjugated to a larger carrier molecule, such as a protein or lipid (¶[0785-0787]; instant claim 16).
Rauch teaches the immunogenic compositions comprising the SARS CoV-2 S protein may comprise pharmaceutically acceptable carriers or excipients (¶[0710-0712]; instant claim 17). Rauch teaches the S protein may be delivered as a protein subunit vaccine (¶[0067][0074][1176]) or a nucleic acid, such as RNA that encoded for the S protein once it enters the target cell, and that said nucleic acid encoding said protein may be in a concentration of about 10 ug/mL to about 10 mg/mL (¶[0921-0922][1008]; instant claim 19). Rauch teaches the composition may further comprise an envelope (E) protein, a membrane (M) protein, or a nucleocapsid (N) protein, or an immunogenic fragment of any of these proteins (¶[0093]; instant claim 20).
Rauch therefore teaches every aspect of instant claims 1-3, 8-17, and 19-20, and anticipates the invention encompassed by said claims.
Claims 1, 8-10, 14-15, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gambotto et. al. (US20220087930A1, Priority 03/05/2020; hereafter “Gambotto”.)
The Prior Art
Gambotto teaches recombinant coronavirus (CoV) vaccines which are delivered via microneedle arrays (entire document; see abstract.) Gambotto teaches methods of preventing infection from SARS CoV-2 in a subject through vaccinating against SARS CoV-2 through administration of an immunogenic composition comprising an effective amount of a SARS CoV-2 Spike (S) protein, wherein said S protein is within an pharmaceutically acceptable excipient (reference claim 1; instant claim 17). Preventing infection and vaccination inherently involves delivery to a subject who is not actively displaying signs or symptoms of infection from said virus; Gambotto teaches administration for prophylactic (preventative) responses, which inherently reads upon delivery of such compositions to a subject before onset of infection or disease (¶[0068-0069][0107]). Additionally, Gambotto teaches administration to healthy human volunteers of the vaccine with no detectable SARS CoV-2 antibodies (¶[0010] at clause 23; ¶[0057][0276][0303]). Gambotto teaches that said composition may be delivered intradermally (¶[0043]; Fig. 16), and therefore teaches every aspect of the method of instant claim 1.
Gambotto teaches the subjects who receive the composition will be monitored (Table 1), and that upon initial vaccination, subject will be monitored for at least one hour following administration for the occurrence of any acute hypersensitivity reaction. Subjects will then be asked to monitor symptoms and will be checked up on at 48 hours post-vaccination (¶[0291]), and the local reactions will be monitored, ranked on a scale, and recorded (¶[0292-0298]). Gambotto teaches the SARS CoV-2 S protein may be the full-length protein or a fragment thereof, namely the S1, S2, or RBD fragments of the S protein (¶[0010][0028-0029][0046][0050][0057][0078-0080][0101]; instant claims 8-10). Gambotto teaches SEQ ID NO: 2, which comprises a sequence that aligns with 100% identity to amino acids 417-560 of instant SEQ ID NO: 2 (see ABSS sequence search results for 17/538,412 and 17/009,121; instant claim 14.) Gambotto also teaches the S protein or fragment thereof may be administered as part of a larger fusion protein (¶[0010][0028][0057]; instant claim 15). Gambotto teaches administration of various dosages of the SARS CoV-2 S protein to human subjects, ranging from 5 ug to 80 ug (¶[0275-0276]) wherein the volume of each dose may range from about 0.1 mL to about 1.0 mL (¶[0181]; instant claim 19). Gambotto teaches that additional SARS CoV-2 proteins, such as nucleoprotein (NP or N), may be delivered in the immunogenic composition (¶[0010] “clause 83”;¶[0028][0034][0078][0118]; instant claim 20).
Gambotto therefore teaches every aspect of instant claims 1, 8-10, 14-15, 17, and 19-20, and anticipates the invention encompassed by 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.
Claims 2-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gambotto as applied to claims 1, 8-10, 14-15, 17, and 19-20 above, or, in the alternative, claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rauch as applied to claims 1-3, 8-17, and 19-20 above,
and further in view of Dendere et. al. (Dendere R, et. al. JMIR Biomed Eng 2017;2(1):e3.; hereafter “Dendere”.)
The Prior Art
The teachings of Gambotto and Rauch have been set forth supra. While Gambotto teaches the method of the instant claims and teaches the monitoring of skin reactions immediately following the intradermal inoculation of the SARS CoV-2 S protein compositions, Gambotto fails to mention specific reaction types, such as monitoring induration (hardening and thickening of skin) and erythema (redness) at the inoculation site. Gambotto is also silent as to the use of devices, such as mobile devices, which can take photographs of the inoculation site and perform analyses of any reaction at said inoculation site. Rauch also teaches the methods of the instant claims, and teaches monitoring for redness within hours or days after the inoculation. However, Rauch is silent as to the use of mobile electronic computer devices to photograph and automatically assess any reaction at the inoculation site. However, the use of mobile devices and programs to detect and perform such analyses were known in the art, as evidenced by the teachings of Dendere.
Dendere teaches monitoring a skin reaction 48 to 72 hours after a tuberculosis intradermal test is performed (entire document; see abstract, “Introduction”.) Dendere teaches that the tuberculin skin test (TST) is a proxy measure for previous exposure to Mycobacterium tuberculosis (MTB), and it is an intradermal test wherein the result is measured 48 to 72 hours after the inoculation (p. 2, left col., ¶2.) Dendere teaches that the test measures skin induration, and that they show a smartphone may be used to capture images of the induration using the camera on said smartphone (p. 2, left col., ¶2-3), wherein the images are subjected to a program to analyze and diagnose the skin induration using reconstructed 3D scenes (p. 2, ¶ bridging cols.; Figs. 1-3, pp. 2-3 “Methods”.)
Given the teachings of either Gambotto or Rauch, one of skill in the art would be apprised as to intradermal inoculation of SARS CoV-2 S protein for the purpose of eliciting an immune response. Given the teachings of Gambotto or Rauch, one of skill would be apprised as to the necessity of monitoring the inoculation site immediately after and up to a few days after inoculation. Given the teachings of Dendere, one of skill in the art would be apprised as to techniques using a smartphone that could be used to monitor the inoculation site and analyze the severity of any localized response at said site. Therefore, given the combined teachings of Gambotto with those of Dendere, arriving at the limitations of instant claims 2-7 would be obvious to a skilled artisan, or, in the alternative, combining the teachings of Rauch and Dendere would allow one of skill in the art to easily arrive at the limitations of instant claims 4-7.
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Gambotto or Rauch in order to utilize a mobile device, such as a smartphone, to take pictures of the SARS CoV-2 immunogenic composition inoculation site, thereby allowing a computer program to analyze and diagnose any reactions at said inoculation site. One would have been motivated to do so, given the suggestion by Dendere that such a method could be performed using smartphones to analyze reaction site issues for intradermal inoculation sites. There would have been a reasonable expectation of success, given the knowledge that mobile devices such as smartphones are readily available, as taught by Dendere, and also given the knowledge that said phones could be set up to take photos necessary to determine the reaction site status of a patient, as taught by Dendere. 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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gambotto as applied to claims 1, 8-10, 14-15, 17, and 19-20 above, or, in the alternative, claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rauch as applied to claims 1-3, 8-17, and 19-20 above,
and further in view of Baker et. al. (WO2017196979A1, Pub. 11/16/2017; hereafter “Baker”.)
The Prior Art
The teachings of Gambotto and Rauch have been set forth supra. While both Gambotto and Rauch teach the addition of excipients to the immunogenic composition, neither explicitly teach the use of phosphate buffered saline (PBS) with TWEEN™-20 (polysorbate-20) and phenol in the composition at the percentages claimed. However, arriving at certain excipients, such as PBS, polysorbate-20, and phenol, would be obvious optimization steps for a skilled artisan, especially given the guidance from Baker.
Baker teaches immunogenic compositions comprising emulsion adjuvant and one or more active agents or substances formulated for intradermal injection into a subject, wherein the emulsion adjuvant of the immunogenic composition comprises a cationic lipid containing a polar head group and a hydrophobic component (entire document; see abstract.) Said immunogenic compositions can be used in treatment and/or prevention of infectious viral disease (p. 11, ¶6-7; p. 12, ¶2), and can comprise viral antigens combined with adjuvants (p. 18, ¶1). Said compositions would comprise pharmaceutically acceptable carriers, such as phosphate buffered saline (PBS), stabilizers, and preservatives (p. 20, ¶4), and would ideally comprise a cationic lipid, a non-ionic surfactant, and an organic solvent (p. 3, ¶2), wherein the non-ionic surfactant may be polysorbate-20 (TWEEN™-20)(pp. 4-5, ¶ bridging pages; reference claim 5). The adjuvant may further comprise phenols (p. 53, ¶2).
Given the teachings of Gambotto or Rauch, one would be apprised as to methods of intradermally delivering immunogenic compositions to elicit an immune response against SARS CoV-2 by delivering S protein antigens. Given the teachings of Baker, one of skill in the art would be apprised as to further adjuvanting agents that could be added to immunogenic compositions intended for intradermal delivery. Given the high level of skill in the art, one would be apprised as to the routine optimization techniques undertaken to determine optimal dosages and concentrations of components to aid in stabilization of immunogenic compositions as well as enhancement of immune responses in a host. Therefore, given the combined teachings of Gambotto or Rauch in view of Baker, it would have been obvious to a skilled artisan to arrive at the limitations of instant claim 18.
It would have been obvious to one of ordinary skill in the art to modify the methods taught by Gambotto or Rauch in order to optimize the excipients and concentrations thereof in the immunogenic composition, thereby generating the most stable, immunogenic composition comprising the SARS CoV-2 S protein antigens. One would have been motivated to do so, given the suggestion by Baker that immunogenic compositions for intradermal delivery would optimally comprise adjuvants and stabilizing agents such as polysorbate-20 and phenol. There would have been a reasonable expectation of success, given the knowledge that said reagents were common excipients in intradermal immunogenic compositions, as taught by Baker. 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.
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.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671