DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of Group I (Claims 1-20, 24, 26, 28, and 30) and the following species:
A live attenuated measles virus, live attenuated rubella virus, and live attenuated Coronavirus each present at a dose of at least 3 log10 CCID50 per mL as the distinct set of viruses;
A stabilizer with the following components:
Sorbitol present at a concentration of 1 to 10% (w/v) for the carbohydrate;
An amino acid selected from the group consisting of tricine present at a concentration of 0.1 to 2% (w/v), L-histidine present at a concentration of 0.1 to 2% (w/v), L-alanine present at a concentration of 0.01 to 1% (w/v), and L-arginine hydrochloride present at a concentration of 0.1 to 5% (w/v); and
At least one hydrolyzed protein selected from a group consisting of gelatin present at a concentration of 0.1 to 5% (w/v) and lactalbumin hydrolysate present at a concentration of 0.1 to 2% (w/v);
Aluminum hydroxide as the adjuvant;
The immunostimulatory component and pharmaceutically acceptable additive have been cancelled; Examiner is taking this as an election of both components being absent; and
Water as the aqueous solution
in the reply filed on 29 July 2026 is acknowledged. The traversal is on the ground(s) that Group II does not pose a significant search burden when searching for Group I. This is not found persuasive because Applicant is applying a different standard to traverse the restriction requirement. Search burden is irrelevant to National Stage (371) applications.
The requirement is still deemed proper and is therefore made FINAL.
Claims 21-23, 25, 27, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 29 July 2026.
It is noted that Examiner required “one or a distinct set” of amino acids and hydrolyzed proteins in the Requirement for Restriction/Election mailed 01 June 2026, see section 6. Applicant’s election does not make it clear if all of the elected amino acids and hydrolyzed proteins are required in the stabilizer, or if just one if required. Applicant is requested to further clarify the stabilizer election and note exactly which components are present. If only one is required, Applicant should elect only one and not one “selected from the group consisting of”. For purposes of applying prior art in this action, Examiner will examine the claims as written, requiring “at least one” amino acid and hydrolyzed protein.
Claim Status
3. Claims 3-11, 13-15, 17, and 19 are cancelled.
Claims 21-23, 25, 27, and 29 are withdrawn.
Claims 1-2, 12, 16, 18, 20, 24, 26, 28, and 30 are under consideration.
Priority
4. The Instant Application is a National Stage (371) of PCT/IN2022/050805 filed 08 September 2022, which claims priority to foreign application IN202121040801 filed 08 September 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Therefore, the effective filing date for purposes of applying prior art is 08 September 2021.
5. It is noted that the most recently-filed Instant Specification does not have a statement referencing the prior-filled foreign priority application. While not required, it is encouraged by the Office to provide an explicit incorporation by reference statement. See MPEP 213.02(I).
Information Disclosure Statement
6. The information disclosure statement (IDS) submitted on 08 March 2024 was filed before the mailing date of the Non-Final Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
7. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
8. 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.
9. The attempt to incorporate subject matter into this application by reference to the recited
reference sequence IDs, such as GenBank accession numbers, NCBI references, and protein IDs is
ineffective because they do not provide the actual sequences that they are referring to. In addition, page 15 of the Instant Specification states that the sequences were available as of 05 September 2022. Therefore, any reference to these sequences in any future claims would not have priority to the earliest date of 08 September 2021.
10. The disclosure is objected to because of the following informalities: there are multiple tables with the same number.
Appropriate correction is required.
Claim Objections
11. Claims 1-2, 12, 20, 24, 26, 28, and 30 are objected to because of the following informalities:
Regarding claim 1, “wherein the virus” should be rewritten as “one of the viruses” for clarity.
Regarding claims 1, 20, and 30, “not less than” should be rewritten as “at least” for clarity.
Regarding claim 2, the ‘C’ in “Claim 1” should be lowercase.
Regarding claim 12, “comprising of” should just be “comprising”.
Regarding claims 20, 24, 26, 28, and 30, “an amino acid consisting of any one or more of tricine… or L-arginine hydrochloride present at a concentration of 1.6% (w/v)” should be rewritten as “an amino acid selected from the group consisting of tricine… L-arginine hydrochloride present at a concentration of 1.6% (w/v), and combinations thereof”.
Regarding claims 24, 26, and 28, “hrs” should be spelled out as “hours” and “more than” in the last line should be rewritten as “greater than”.
Regarding claim 24, “10x” should be rewritten as “10 times the”.
Appropriate correction is required.
Claim Interpretation
12. Claims 24, 26, and 28 are interpreted as product-by-process claims, where "obtained by a process comprising the steps of" is a product-by-process limitation. Claims 24, 26, and 28 require a live attenuated Coronavirus, measles virus, and rubella virus, respectively, but do not require the method steps recited in the claims. MPEP § 2113 makes clear that "Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps" and that "determination of patentability is based on the product itself." Therefore, the broadest reasonable interpretation of the live attenuated viruses in claims 24, 26, and 28 are the live attenuated viruses themselves.
Claim Rejections - 35 USC § 112(b)
13. 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.
14. Claims 1-2, 12, 16, 18, 20, 24, 26, 28, and 30 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 20 and 28 are indefinite because they depend on cancelled claim 19. Examiner is interpreting both claims to be dependent on claim 1.
Regarding claims 1, 20, 24, 26, 28, and 30, “(w/v)” renders the claim indefinite because it is unclear whether it is an example or a required limitation due to the parentheses.
Claims 2, 12, 16, 18, 20, 24, 26, 28, and 30, which depend on claim 1, are similarly rejected.
Claim 2 recites the limitation "the desired characteristics… including stability and immunogenicity" renders the claim indefinite because they are examples and the genus is not fully defined.
Claims 12, 16, and 18 recite the limitation "the vaccine composition". There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 20 and 28, “a carbohydrate consisting of any one or more of” is unclear because it references a group but only lists sorbitol. This could be interpreted as just requiring sorbitol or sorbitol plus other carbohydrates. However, it is noted that if there are other carbohydrates, this would not read on the species election of sorbitol as the carbohydrate.
Regarding claims 20, 24, 26, and 30, “a hydrolyzed protein consisting of any one or more of…” is unclear because “a hydrolyzed protein” implies that there is one protein but two are recited.
Regarding claims 24, 26, and 28, “cell factories” is unclear because one of ordinary skill could interpret it as a cell, a bioreactor, or a manufacturing plant. Thus, there are multiple structural interpretations.
The term “about” in claims 24, 26, and 28, is a relative term which renders the claim indefinite. The term “about” 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. The acceptable range that could encompass “about” could be interpreted differently by different people.
Regarding claim 30, a) and b) make the claim indefinite because one of ordinary skill could interpret a) and b) as being two separate compositions or a) and b) being the same composition, wherein a) is in a first container, resulting in b). Thus, there are multiple structural interpretations.
Regarding claim 30, “(freeze-dried)” renders the claim indefinite because it is unclear whether it is an example or a required limitation due to the parentheses.
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Claim Rejections - 35 USC § 112(d)
15. 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.
16. Claim 2 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. Claim 2 states “a vaccine composition that preserves the desired characteristics of each virus, including stability and immunogenicity.” These characteristics are examples of inherent properties of the composition, and thus do not further limit the composition of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
17. 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.
18. 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.
19. Claims 1-2, 16, 18, 20, 24, 26, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over McAleer (EP 0028563 A1; Published 13 May 1981) in view of Qiao (US 20160228369 A1; Published 11 August 2016).
Regarding claims 1-2, 18, 20, 24, 26, and 28, McAleer teaches “The present invention is directed to a stabilized vaccine composition in liquid form containing a live virus, partially hydrolyzed gelatin, a monosaccharide or disaccharide, a cell culture medium, L-glutamic acid, L-arginine and sufficient physiologically acceptable acidic buffer to maintain the pH at from about 6.0 to about 6.5. The liquid vaccine may be obtained by thawing a frozen vaccine or by reconstituting a lyophilized vaccine. Examples of live virus are measles, mumps or rubella, … or a combination of any two or more of such viruses.” (DETAILED DESCRIPTION, ¶ 1), wherein the monosaccharide in the stabilizer can be sorbitol (DETAILED DESCRIPTION, ¶ 3). The tables on pages 6-7 show the components and a preferred embodiment (using L-arginine HCl), respectively:
Page 6:
PNG
media_image1.png
178
434
media_image1.png
Greyscale
Page 7:
PNG
media_image2.png
169
296
media_image2.png
Greyscale
In summary, McAleer teaches a liquid composition with live attenuated viruses that has partially hydrolyzed gelatin, sorbitol, and L-arginine HCl with a final pH of 6.0-6.5. The composition can comprise two or more viruses, including measles and rubella. McAleer also teaches that the liquid composition can be obtained through reconstituting a lyophilized vaccine and that lyophilization has been traditionally used as a stabilization method in the past (BACKGROUND OF THE INVENTION, ¶ 5). McAleer does not teach the specific concentrations of each of the ingredients, the doses of the live attenuated viruses, or a coronavirus as a possible option.
However, Qiao teaches “the present invention provides dry formulations of vaccines that comprise a live attenuated parvovirus, e.g., CPV, 10% to 80% (w/w) of sorbitol as the sugar alcohol, a combination of 5% to 30% (w/w) of glycine and 5% to 40% (w/w) of dextran as the bulking stabilizer, a combination of 2% to 25% (w/w) gelatin with 2% to 25% (w/w) of a proteolytic hydrolysate of whole casein as the protein stabilizer; and a buffer having a pH of 6.5 to 7.8. In certain embodiments of this type, 10% to 50% (w/w) arginine is included as an amino acid stabilizer. In specific embodiments, the buffer is 0.2% to 5% (w/w) potassium or sodium phosphate, pH 6.5 to 7.8.” (¶ [0055]). Furthermore, the vaccine can include multiple and different viruses: “The present invention provides room temperature stable multivalent vaccines comprising human, livestock, or companion animal viruses as detailed herein. Examples of room temperature stable multivalent canine vaccines of the present invention, include but are in no way limited to: two or more of the following live attenuated viruses or recombinant vectors ….canine coronavirus” (¶ [0111]).
Therefore, Qiao teaches a live attenuated vaccine for canines with a mix of compounds that reads on the stabilizer for a similar purpose. The vaccine can include canine coronavirus, but it can also be used with human viruses. It would have been obvious to one of ordinary skill before the filing date to take the composition of McAleen and further include a live attenuated human coronavirus, as Qiao’s composition shows that a similar composition will work with other coronaviruses. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding the compound concentrations and final pH of the compound, both McAleen and Qiao give ranges for their individual components which shows that these values would be routinely optimized by a person of ordinary skill depending on the viruses present, their concentration, and the compounds’ effect on stabilizing the viruses. Similarly, doses are in the art to be result-effective and thus are routinely optimized as well. A greater concentration of virus would result in a greater immune response, while a lower concentration of virus would result in a weaker immune response. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Regarding claim 16, Qiao further teaches “Accordingly, the room temperature stable vaccines of the present invention may be freeze-dried (or otherwise reduced in liquid volume) for storage, and then reconstituted in a liquid carrier, e.g., with a pharmaceutically acceptable carrier such as a vaccine-grade water…” (¶ [0078]).
Regarding claim 30, a kit is a collection of components. McAleen in view of Qiao teach the composition in claim 1. Qiao further teaches freezing the vaccine formulation into containers, such as a vial (¶ [0058]). If the dry vaccine composition is to be reconstituted so that it can be administered, another vial with vaccine-grade water would be obvious to include. Therefore, McAleen and Qiao teach or make obvious all the components recited in the kit. Therefore, the prior art fulfills the limitations of the kit comprising a)-c), by teaching the components of the kit. See In re Venezia 189 USPQ 49 (CCPA 1976), where kits are drawn to the structural attributes of interrelated component parts and not to activities that may or may not occur.
20. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over McAleen (Supra) and Qiao (Supra) as applied to claims 1-2, 16, 18, 20, 24, 26, 28, and 30 above, and further in view of He (February 2015, Human Vaccines & Immunotherapeutics, 11(2): 477-488).
Regarding claim 12, McAleen in view of Qiao teach all the limitations of claim 1 as discussed supra. All discussions thereon incorporated here. Qiao further teaches “multiple vaccine antigens can be combined and stored as a single dry formulation, and then prior to administration can be mixed together with a pharmaceutically acceptable carrier and one or more other vaccine antigens that had been stored in one or more separate dry formulation(s).” (¶ [0086]) wherein the “carrier” can refer to an adjuvant (¶ [0087]). Neither McAleen nor Qiao teach that the adjuvant can be aluminum hydroxide.
However, He teaches “aluminum hydroxide is the most commonly used chemical as adjuvant” (Abstract). Therefore, it would have been obvious to one of ordinary skill before the filing date to take the composition made obvious by McAleen and Qiao, and further use aluminum hydroxide as the adjuvant. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Double Patenting
21. 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.
22. Claims 1-2, 12, 16, 18, 20, 24, 26, 28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10, and 15-16 of U.S. Patent No. 12,364,747 in view of McAleer (EP 0028563 A1; Published 13 May 1981), Qiao (US 20160228369 A1; Published 11 August 2016), and He (February 2015, Human Vaccines & Immunotherapeutics, 11(2): 477-488).
Claim 1 of ‘747 states an immunogenic composition comprising a) one or more Influenza viruses at a dose of 6 to 7 Log EID50 per 0.5 mL, and b) a stabilizer composition comprising i. 1 to 10% (w/v) sucrose; ii. 0.1% to 2% (w/v) of histidine; iii. 0.01% to 1% (w/v) alanine; iv. 0.1% to 2% (w/v) tricine; v. 0.1 to 5% (w/v) arginine; and vi. 0.1 to 5% (w/v) gelatin. Claim 2 of ‘747 states that the influenza virus can be live attenuated and claim 10 states that the composition can comprise an aluminum hydroxide adjuvant. Claim 15 of ‘747 states that the final pH of 6.5 and claim 16 narrows the preferred dose to NLT 6.5 Log EID50 per 0.5 mL. The claims of ‘747 do not recite sorbitol in the stabilizer; rubella, measles, and coronavirus as the viruses; the doses of each virus; or a lyophilized composition. However, the combination of McAleer, Qiao, and He render obvious claims 1-2, 12, 16, 18, 20, 24, 26, 28, and 30 as discussed supra. All obviousness arguments above incorporated here. The addition of claims 1-2, 10 and 15-16 of ‘747 only further support this obviousness and thus the prior art combined with said claims renders the instant claims above obvious.
23. Claims 1-2, 12, 16, 18, 20, 24, 26, 28, and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-9, 14, 18, and 20 of copending Application No. 19/507,811 in view of McAleer (EP 0028563 A1; Published 13 May 1981), Qiao (US 20160228369 A1; Published 11 August 2016), and He (February 2015, Human Vaccines & Immunotherapeutics, 11(2): 477-488).
Claim 1 of ‘811 states a lyophilized or freeze-dried viral vaccine composition comprising a) one or more virus particles or antigens thereof and b) a stabilizer comprising one or more sugar or sugar alcohol, one or more amino acids, lactalbumin hydrolysate, and gelatin. Claim 2 of ‘811 states that the virus can be selected from a group consisting of measles virus, rubella virus, and coronavirus. Claim 3 of ‘811 states that the virus can be a live attenuated virus. Claim 8 of ‘811 states that the sugar or sugar alcohol can be sorbitol or the amino acid can be tricine, L-histidine, L-arginine hydrochloride, or L-alanine. Claim 9 of ‘811 states that the stabilizer comprises 1 to 20% (w/v) sorbitol; or 0.1 to 2% (w/v) tricine, 0.1 to 2% (w/v) L-histidine, 0.01 to 1% (w/v) L-alanine, and 0.1 to 5% (w/v) L-arginine hydrochloride; or 0.1 to 10% (w/v) gelatin and 0.05 to 2% (w/v) lactalbumin hydrolysate. Claim 14 of ‘811 states that the composition can comprise an adjuvant, wherein the adjuvant can be aluminum hydroxide. Claim 18 of ‘811 states that the lyophilized or freeze-dried viral vaccine can be reconstituted with water for injection (WFI) and claim 20 states that the final pH is 6.0 to 7.5. The claims of ‘811 do not recite the doses of the viruses. However, the combination of McAleer, Qiao, and He render obvious claims 1-2, 12, 16, 18, 20, 24, 26, 28, and 30 as discussed supra. All obviousness arguments above incorporated here. The addition of claims 1-2, 10 and 15-16 of ‘747 only further support this obviousness and thus the prior art combined with said claims renders the instant claims above obvious.
This is a provisional nonstatutory double patenting rejection.
Conclusion
24. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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 at (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.
/KRISTINA E. LY/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
