DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-4 are pending in the present application and currently under examination.
Priority
This application is a national stage 371 application of PCT/RU2021/000277 filed 29 June 2021. This application claims foreign priority of RU2020123853 filed 17 July 2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. However, the foreign priority document received on 17 January 2023 is not in English, and therefore, the examiner cannot ascertain whether said document discloses the invention for purposes of priority. Consequently, the effective filing date, for purposes of applying prior art, is 29 June 2021 (the date PCT/RU2021/000277 was filed).
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement (IDS)
The IDS (1) filed on 17 January 2023 has been considered by the examiner. A signed copy is enclosed.
There is an extensive list of references (56 total) cited in the specification while the single IDS only lists seven (7) references. 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.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 2 does not fall within at least one of the four categories of patent eligible subject matter because the claim is drawn to the use of derivative of synthetic phthalhydrazide as an adjuvant and not a composition of matter, machine, manufacture, or process.
“Use” claims that do not purport to claim a process, machine, manufacture, or
composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129
USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the
categories of patentable inventions specified in 35 U.S.C. § 101”). In Ex parte Dunki, 153 USPQ
678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a
process: “The use of a high carbon austenitic iron alloy having a proportion of free carbon as a
vehicle brake part subject to stress by sliding friction.” In Clinical Products Ltd. v. Brenner, 255
F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was
definite, but that it was not a proper process claim under 35 U.S.C. 101: “The use of a sustained
release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid.”
Although a claim should be interpreted in light of the specification disclosure, it is generally
considered improper to read limitations contained in the specification into the claims. See In re
Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188
USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to
impart limitations to the claim that are not recited in the claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 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 claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claims 1, 2, and 3 recite the limitation: a derivative of synthetic derivatives of phthalhydrazide (Abidov’s adjuvant). It is unclear whether the subject-matter enclosed by the parenthesis, ‘Abidov’s adjuvant,’ is a further limitation of the claim or merely an example of a derivative of synthetic phthalhydrazide derivatives. One of ordinary skill in the art would be unable to determine if they were infringing on the claims or not because the boundary of the claims is unclear as to whether each claim includes all derivatives of synthetic phthalhydrazide derivatives or only Abidov’s adjuvant.
Claim 2 is indefinite for attempting to claim a process without setting forth any steps in the process. Claim 2 recites the use of synthetic phthalhydrazide derivatives (Abidov’s adjuvant) as an adjuvant to increase the immunogenicity of agents for specific immunological prophylaxis of infectious diseases, regardless of their nature. Claim 2 is attempting to use the synthetic phthalhydrazide derivatives to increase the immunogenicity of agents for specific immunological prophylaxis of infectious diseases, which is a process of use. However, claim 2 does not recite any steps of this process and is therefore indefinite. See MPEP 2173.05(q).
Claims 2 and 3 recite the limitation “regardless of their nature.” First, it is unclear which term – the agents or the infectious diseases – this limitation is serves to limit. Second, the specification does not define what “regardless of their nature” entails or why it is necessary within the claim. Simply stating “infectious diseases” would include all infectious diseases without the need for a further limitation reiterating this.
Claim 4 recites the limitation: “for each of the antigen (anatoxin)…” It is unclear whether the subject-matter enclosed by the parenthesis, ‘anatoxin,’ is a further limitation of the claim or merely an example of a type of antigen. One of ordinary skill in the art would be unable to determine if they were infringing on the claim or not because the boundary of the claim is unclear as to whether it includes all antigens or an anatoxin antigen in the context of an immune response.
Claim 4 contains additional issues and therefore indefinite for the following reasons:
Claim 4 recites the limitation, “[t]he method according to p. 2.” It is unclear if applicant is referring to the specification or this is a typographical error and referencing claim 2. Page 2 of the specification does not allude to a method as described in claim 4 and claim 2 is not drawn to a method. Therefore, there is insufficient antecedent basis for this limitation in the claim. Applicant is reminded that incorporation by reference to figures or tables “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP 2173.05(s).
Claim 4 also recites, “Abidov’s adjuvant is used…” However, none of the previous claims specifically require Abidov’s adjuvant (please see rejection above as that which is claimed in the parenthesis is not a limitation of the metes and bounds of the claim). Therefore, there is lack of antecedent basis for this claim.
Claim 4 recites “Abidov’s adjuvant is used in a single dose of 300 μg/ml (150 μg/individual) intramuscularly in a syringe when administered separately from an antigen or immunogen.” This is a use claim that omits essential steps such as who (or what) the adjuvant is administered to. Furthermore, it is unclear if the term ‘150 μg/individual’ included in the parenthesis serves to limit the claim further or is merely an example of a dose and one of ordinary skill in the art would be unable to determine if they were infringing on the claim or not because the boundary of the claim is unclear.
The next part of claim 4 recites, “…used at a dose of 0.01 to 1000 mg/ml simultaneously with the antigen or immunogen introduction” does not even recite the antigen is administered. This is a use claim that omits essential element steps as it is unclear how the dose of 0.01 to 1000 mg/ml is ‘used’ without administration to someone or something.
Finally, the remaining part of the claim, drawn to the effects of the adjuvant, recites:
1. the immunogenicity of inactivated and chemical vaccines is increased by at least 3 times,
2. the immunogenicity of live vaccines is increased without affecting their safety by means of reducing reactogenicity,
3. polyanatoxin association immunogenicity increases by at least 30% for each of the antigen (anatoxin) included in the association.
Since there is no ‘and’ or ‘or’ terminology separating the final group of effects from the previous group, it is unclear whether this claim requires all three of the aforementioned effects or just one. Furthermore, it is unclear whether these effects are intended to be the result of administration with a single dose of 300 μg/ml, at a dose of 0.01 to 1000 mg/ml, or both. If the latter is true, where the effects are intended to also include the dose of 0.01 to 1000 mg/ml, then this aspect of the claim also omits essential steps as it is unclear how these three effects would occur without some sort of active step (e.g., administration to a subject).
Claim Rejections - 35 USC § 103
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Henry (US 2018/0153889 A1, published: 07 June 2018).
Henry discloses modulation of cell fates and activities by phthalazinediones (title). Henry discloses phthalolhydrazide, phthalazinedione, and phthalazine derivatives have been described in the literature as having anti-inflammatory, anti-cancer, and anti-hypoxic effects.
Henry discloses phthalazinedione compounds including 5-amino-2,3-dihydrophthalazine-l ,4-dione (luminol) and a method of manufacturing the sodium salt of luminol ([0008]). Henry further discloses the sodium salt of luminol and its pharmaceutical use for immunomodulation, inflammation, and anti-oxidant treatment ([0008]). Henry further discloses using phthalazinedione treatment to treat infectious diseases such as HIV ([0210]).
Regarding instant claim 3, Henry discloses pharmaceutical compositions containing phthalazinediones also include an antibiotic, antiviral agent, anti-inflammatory agent, immunomodulator, etc. ([0021], tetracycline at [0057]).
Specifically, Henry discloses the therapy using phthalazinediones includes combined treatment with phthalazinediones and compounds to replace lost thiols, oxidatively protect the subject, eliminate the source of stress, or otherwise support the subject in fighting a particular condition ([0057]). The additional component in the combined therapy may be: an amino acid, antibiotic, antiviral agent, anti-inflammatory agent, antioxidant, immunomodulator, reductant, oxidative protector, steroid, or vitamin ([0057]). Furthermore, the additional compound may be administered simultaneously, separately, or sequentially, with a preferred method of administration of phthalazinedione + additional component administered simultaneously ([0057]). Finally, Henry discloses administration intramuscularly ([0058]).
It would have been prima facie obvious, before the effective filing date of the claimed
invention, to use the teachings of Henry to arrive at the claimed invention set forth in instant claim 3 because Henry explicitly discloses each of the limitations contained within this claim. Specifically, Henry discloses synthetic phthalazinediones, including sodium luminol, and its use in treating infectious diseases such as HIV. Henry further discloses administering these phthalazinediones simultaneously and intramuscularly with an amino acid, antibiotic, antiviral agent, anti-inflammatory agent, antioxidant, immunomodulator, reductant, oxidative protector, steroid, or vitamin. Therefore, one of ordinary skill could envision the currently claimed invention stemming from the disclosures made by Henry with reasonable expectation of success because the embodiment of the currently claimed invention was entirely taught by the prior art.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Henry (US 2018/0153889 A1, published: 07 June 2018) in further view of Nicholls (“Immunomodulators as adjuvants for vaccines and antimicrobial therapy,” published 04 October 2010).
Henry discloses modulation of cell fates and activities by phthalazinediones (title). Regarding the limitations set forth in instant claim 1:
Henry discloses phthalolhydrazide, phthalazinedione, and phthalazine derivatives have been described in the literature as having anti-inflammatory, anti-cancer, and anti-hypoxic effects.
Henry discloses phthalazinedione compounds including 5-amino-2,3-dihydrophthalazine-l ,4-dione (luminol) and a method of manufacturing the sodium salt of luminol ([0008]). Henry further discloses the sodium salt of luminol and its pharmaceutical use for immunomodulation, inflammation, and anti-oxidant treatment ([0008]).
Henry discloses that because of their antioxidant, anti-inflammatory, antipoliferative, immunomodulatory, redox-buffering, and non-toxic properties, amino phthlazinediones are beneficial as adjunctive support therapy for stressed cells ([0061]).
Henry discloses the phthalazinediones are administered by various routes, wherein the second most common route is intramuscular injection ([0023], [0132]).
Henry discloses the treatment using phthalazinediones can be prophylactic to prevent or delay the onset of the disease or to prevent the manifestation of clinical or subclinical symptoms thereof ([106]).
Henry discloses pharmaceutical composition containing phthalazinediones can be administered to a subject to treat inflammatory conditions, infectious conditions, immune disorders, etc. ([0023]). Henry further discloses using phthalazinedione treatment to treat infectious diseases such as HIV ([0210]).
Henry discloses the pharmaceutical compositions containing phthalazinediones can also include pharmaceutically-acceptable, non-toxic carriers or diluents ([0134]).
Regarding the limitations set forth in instant claim 2:
Henry discloses the pharmaceutical compositions containing phthalazinediones also include an antibiotic, antiviral agent, anti-inflammatory agent, immunomodulator, etc. ([0021], tetracycline at [0057]).
Specifically, Henry discloses the therapy using phthalazinediones includes combined treatment with phthalazinediones and compounds to replace lost thiols, oxidatively protect the subject, eliminate the source of stress, or otherwise support the subject in fighting a particular condition ([0057]). The additional component in the combined therapy may be: an amino acid, antibiotic, antiviral agent, anti-inflammatory agent, antioxidant, immunomodulator, reductant, oxidative protector, steroid, or vitamin ([0057]). Furthermore, the additional compound may be administered simultaneously, separately, or sequentially, with a preferred method of administration of phthalazinedione + additional component administered simultaneously ([0057]).
Regarding the limitations set forth in instant claim 4:
Henry discloses the phthalazinedione at a therapeutically effective dose will be in the range of approximately 0.01 to 100.0 mg/kg of body weight or about 1.0-10,000.00 mg per day ([0038]). As previously discussed, Henry further discloses administration of phthalazinedione + additional component simultaneously as the preferred method of administration ([0057]).
Henry discloses a derivative of synthetic phthalhydrazide derivatives with the same structure as Abidov’s adjuvant simultaneously administered in combination with an immunogen at an identical dose. Therefore, the following limitations of claim 4 are considered inherent properties (see MPEP 2112 (I, II, and III):
The immunogenicity of inactivated and chemical vaccines is increased by at least 3 times;
The immunogenicity of live vaccines is increased without affecting their safety by means of reducing reactogenicity; and
Polyanatoxin association immunogenicity increases by at least 30% for each of the antigens included in the association.
While Henry discloses phthalazinediones act as immunomodulators (“phthalazinediones of the invention may be used to modulate redox imbalances…” ([0017])), Henry does not disclose phthalazinediones as vaccine adjuvants as required by instant claims 1, 2, and 4.
Nicholls teaches immunomodulators as adjuvants for vaccines and antimicrobial therapy (title). Specifically, Nicholls teaches a highly effective strategy for combating infectious diseases by enhancing host defenses using immunomodulators, either preventatively, through vaccination, or therapeutically (abstract). Nicholls discusses the development of new vaccines necessitates the development of new types of adjuvants to ensure an appropriate immune response (abstract). Furthermore, Nicholls contemplates various immunomodulators, such as TLR ligands, are attractive vaccine adjuvant candidates (p. 50). While Nicholls does not explicitly teach phthalazinediones as immunomodulator vaccine adjuvants, Nicholls suggests immunomodulators are attractive vaccine adjuvant candidates, especially in the realm of infectious diseases.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Henry in view of Nicholls. Henry discloses all of the currently claimed elements, including phthalazinediones as immunomodulators and use in conjunction with other compounds in a pharmaceutical composition, but does not explicitly disclose phthalazinediones as adjuvants. Nicholls has been cited for teaching immunomodulators are promising adjuvants for new vaccines for infectious diseases. Armed with the teachings of Henry and Nicholls, it would have been prima facie obvious to one of ordinary skill in the art, at the time of the currently filed invention, to use phthalazinediones as adjuvants in view of the express suggestion of Nicholls.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Co-pending application 18/016,652
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/016,652 (reference application ‘652).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to a vaccine for the immunological prophylaxis of infectious diseases which contains a derivative of synthetic derivatives of phthalhydrazide as an adjuvant and pharmaceutically acceptable carriers and/or diluents.
The current application claims more broadly the invention disclosed in ‘652 (coronavirus infection of ‘652 [Wingdings font/0xE0] infectious disease; Tamerit adjuvant of ‘652 [Wingdings font/0xE0] derivative of synthetic derivatives of phthalhydrazide).
Regarding instant claim 1, ‘652 claims a vaccine for protection against coronavirus infection containing the adjuvant Tamerit (see ‘652 claim 1).
Regarding instant claim 2, ‘652 claims using phthalhydrazide derivatives to increase the clinical and laboratory efficacy of antiviral agents or antimalarial agents (see ‘652 claim 3).
Regarding instant claim 3, ‘652 claims administration of Tamerit in combination with an antiviral or antimalarial agent (see ‘652 claim 3).
Regarding instant claim 4, ‘652 claims administration of Tamerit in combination with an antiviral or antimalarial agent, wherein Tamerit is administered at a dose of 0.01 to 4000 mg/kg (see ‘652 claim 3). The range of Tamerit dosing encompasses the currently claimed range in instant claim 4. See MPEP 2144.05(I).
Both ‘652 and the currently claimed invention are directed to overlapping embodiments, and therefore, instant claims 1-4 are anticipated by claims 1-3 of the ‘652 co-pending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-4 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A Rossi whose telephone number is (571) 272-0138. The examiner can normally be reached M-F 8:30-5:00.
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, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A ROSSI/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644