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 .
Priority
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/227,320, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The application claims priority as a CIP to Application No. 17/227,320, yet the specification of said application does not provide support for any of the claims of the instant application.
Applicant’s claim for the benefit of a prior-filed application CON of PCT/US22/16367 14 February 2022 which claims benefit of 63/149,082 12 February 2021 is acknowledged. Therefore, the effective filing date of the instant application is 12 February 2021.
Claim Status
Claims 1-19 have been considered on their merits.
Claim Objections
Claim 9 is objected to because of the following informalities: the abbreviation “MCT4” for mono-carboxylate transporter 4 protein should be spelled out upon first use.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims disclose a method for eliminating hyperproliferative cells in the body of an organism, said method comprising: a) engineering a flu virus in culture to favor binding and infective activity of a target cell in a zone of elevated body temperature; b) engineering a flu virus in culture to favor binding and infective activity of a target cell in a zone of elevated [H+]; c) continue engineering said flu virus to produce in culture a virion that favors both elevated temperature and elevated [H+]; d) introducing said virion into said body; and wherein said virion focuses in one or more zones of elevated [H+] and temperature to increase anti-viral immune response in said one or more zones.
Engineering a flu virus
The scope of “engineering a flu virus” by the claimed method is broad to encompass any known method of viral engineering for any known influenza virus. Claim 1 requires engineering, by growing in culture in undefined conditions that favor binding and infective activity at elevated temperature, a flu virus to favor binding a target cell in a zone of elevated body temperature and also a zone of elevated [H+]. The instant specification provide no guidance pertaining to the methods used to engineer said influenza virus.
The instant specification provides prophetic examples of how one may engineer a virus using culture conditions to favor binding and infective activity at reduced pH (p. 6, line 27) or molecular biology and/or mutated or adapted using serial culture (p. 16, lines 2-4). However, the instant claims and specification fail to provide how to carry out the steps in order to produce an engineered flu virus that favors binding cells in a zone of elevated temperature or [H+]. The state of the art is completely silent on how to make or use an engineered influenza virus which (1) favors binding a target cell in a zone of elevated body temperature and also (2) favors binding a target cell in a zone of elevated [H+], therefore the disclosure must provide the teaching for one of ordinary skill in the art to carry out said invention.
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Although the prior art is silent on the critical features of the instant invention, the post-filing art has some knowledge of influenza virus used in cancer therapies. Post filing art, Kabiljo et al. (of record), is optimistic about the prospects for oncolytic influenza A viruses, despite the fact that at the date of Kabiljo et al., "only preclinical studies had been accomplished" (page 2, col. 1 ). Kabiljo et al. state that "influenza A viruses have a two-sided relationship to apoptosis." Kabiljo et al. provide Fig.2 (page 2) which describes the positive and negative feedback mechanisms that apoptosis plays in the influenza A virus lifecycle:
The examiner is unsure if this complex role for apoptosis in the influenza A virus lifecycle suggests unpredictability in practicing the instant invention's requirement for apoptotic cell death. However, it does seem that the post-filing art recognizes this could be a complicating factor in the use of such viruses for oncolysis.
Regarding how influenza A viruses can be targeted to malignant cells, Kabiljo et al. (page 4, Influenza A viruses can be targeted to malignant cells section) describe the state of the art, after the filing date of the instant application. Kabiljo et al. describe Egorov's influenza A virus lacking NS1 as capable of infecting tumor cells compared to healthy, normal tissue, because "cancer cells downregulate components of the IFN signaling pathway, attenuation of the NS1 protein appeared to be an attractive strategy for targeting growth of influenza A viruses to malignant tissue." However, this lack of interferon mechanism of "targeting" does not seem to be based upon the requirements of the instant claims requiring engineering that increases binding at a low pH and high temperature compared to normal influenza A viruses. Kabiljo et al. also describe engineered influenza viruses that target viral entry (Targeting influenza viruses to tumor cells by viral entry section, page 6, col.2). Kabiljo et al. describe modification to the point of cleavage of hemagglutinin (HA). Kabiljo et al. teach "To further target the influenza A virus to tumor tissue we generated a virus in which the conformational change of HA, which enables viral entry, relies on the protease elastase. Elastase has been shown to be present in tumor tissue due to expression by neutrophils ... We therefore exchanged the trypsin cleavage site within the partially NS1 deleted (116AA) PR8 influenza virus to elastase. Elastase-dependent viruses yielded a potent therapeutic efficacy in murine melanoma (B16) and pancreatic ductal adenocarcinoma (PANC-1) xenograft models." However, this substitution at HA cleavage site mechanism of "targeting" does not seem to be based upon the requirements of the instant claims requiring engineering that increases binding at a low pH and high temperature compared to normal influenza A viruses.
Due to the complete lack of a working example and no guidance from the instant disclosure the process of engineering an influenza virus which favors binding and infective activity at elevated [H+] and increased temperature and the lack of working examples from the prior art it would be highly unpredictable.
Therefore, it is concluded that the instant specification fails to provide sufficient written description to reasonably convey to one skilled in the art that the inventor had possession of the entire scope of the claimed invention.
Claims 1-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. See Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916). The key word is 'undue,' not experimentation.' " (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
NATURE OF THE INVENTION
The breadth of the claims encompass methods of engineering an influenza virus to cause an increased anti-viral immune response in a subject to eliminating hyperproliferative cells. In particular, claim 1 is directed to a method for eliminating hyperproliferative cells in the body of an organism, comprising engineering a flu virus in culture to favor binding a target cell in a zone of elevated body temperature; engineering a flu virus in culture to favor binding a target cell in a zone of elevated [H+]; continue engineering said flu virus to produce in culture a virion that favors both elevated temperature and elevated [H+]; introducing said virion into said body; and wherein said virion focuses in one or more zones of elevated [H+] and temperature to increase anti-viral immune response in said one or more zones.
The specification fails to describe the claimed methods and would require undue
experimentation to discover these methods.
GUIDANCE & WORKING EXAMPLES
The specification does not provide a working example for a method for eliminating a hyperproliferative cell, said method comprising engineering a flu virus in culture to favor binding a target cell in a zone of elevated body temperature; engineering a flu virus in culture to favor binding a target cell in a zone of elevated [H+]; continue engineering said flu virus to produce in culture a virion that favors both elevated temperature and elevated [H+]; introducing said virion into said body; and wherein said virion focuses in one or more zones of elevated [H+] and temperature to increase anti-viral immune response in said one or more zones.
The absence of working examples directed to the claimed method necessitates further experimentation. Importantly, the instant application does not provide any working examples of an engineered influenza virus having (1) to favor binding a target cell in a zone of elevated body temperature and also having (2) to favor binding and infective activity of a target cell in a zone of elevated [H+]. Furthermore, the instant specification does not provide any methods for engineering an influenza virus such that it (1) favors binding a target cell in a zone of elevated body temperature and also (2) favors binding and infective activity of a target cell in a zone of elevated [H+]. While the instant specification contains general statements about methods in the prior art for rational manipulation of virus capsids that alter binding affinity of viruses other than influenza virus, there is no guidance for how to engineer this critical component in the instant invention.
Without knowledge of which domains of the influenza virus should be modified or guidance for how to make these double mutations requiring both increased binding and infective activity based upon temperature and increased binding based upon H+ concentration, a person of ordinary skill in the art would be left with an undue burden to discover the necessary changes to produce the required influenza virus modifications. The examiner asks if the claimed methods are reach-through claims, since the applicant is attempting to capture a method for use, where the instant specification only provide incomplete, prophetic guidance for producing the required engineered influenza virus in a manner addressed in University, Rochester v. G.D. Searle Co., 358 F.3d 916 (Fed. Cir. 2004).
Therefore, the specification does not provide sufficient guidance on how to make and use the claimed engineered influenza virus for eliminating hyperproliferative cells in the body of an organism, based upon the engineered influenza virus having (1) increased binding and infective activity compared with a common influenza virus at an increased temperature and also having (2) increased binding and infective activity compared with a common influenza virus at an increased H+ concentration.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
In fact, the state of the art is completely silent on how to make or use an engineered influenza virus which (1) favors binding and infective activity of a target cell in a zone of elevated body temperature and also (2) favors binding and infective activity of a target cell in a zone of elevated [H+].
Although the prior art is silent on the critical features of the instant invention, the post-filing art has some knowledge of influenza virus used in cancer therapies. Post filing art, Kabiljo et al. (of record), is optimistic about the prospects for oncolytic influenza A viruses, despite the fact that at the date of Kabiljo et al., "only preclinical studies had been accomplished" (page 2, col.1 ). Kabiljo et al. state that "influenza A viruses have a two-sided relationship to apoptosis." Kabiljo et al. provide Fig.2 (page 2) which describes the positive and negative feedback mechanisms that apoptosis plays in the influenza A virus lifecycle:
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The examiner is unsure if this complex role for apoptosis in the influenza A virus lifecycle suggests unpredictability in practicing the instant invention's requirement for apoptotic cell death. However, it does seem that the post-filing art recognizes this could be a complicating factor in the use of such viruses for oncolysis.
Regarding how influenza A viruses can be targeted to malignant cells, Kabiljo et al. (page 4, Influenza A viruses can be targeted to malignant cells section) describe the state of the art, after the filing date of the instant application. Kabiljo et al. describe Egorov's influenza A virus lacking NS1 as capable of infecting tumor cells compared to healthy, normal tissue, because "cancer cells downregulate components of the IFN signaling pathway, attenuation of the NS1 protein appeared to be an attractive strategy for targeting growth of influenza A viruses to malignant tissue." However, this lack-of interferon mechanism of "targeting" does not seem to be based upon the requirements of the instant claims requiring engineering that increases binding at a low pH and high temperature compared to normal influenza A viruses. Kabiljo et al. also describe engineered influenza viruses that target viral entry (Targeting influenza viruses to tumor cells by viral entry section, page 6, col.2). Kabiljo et al. describe modification to the point of cleavage of hemagglutinin (HA). Kabiljo et al. teach "To further target the influenza A virus to tumor tissue we generated a virus in which the conformational change of HA, which enables viral entry, relies on the protease elastase. Elastase has been shown to be present in tumor tissue due to expression by neutrophils ... We therefore exchanged the trypsin cleavage site within the partially NS1 deleted (116AA) PR8 influenza virus to elastase. Elastase-dependent viruses yielded a potent therapeutic efficacy in murine melanoma (B16) and pancreatic ductal adenocarcinoma (PANC-1) xenograft models." However, this substitution at HA cleavage site mechanism of "targeting" does not seem to be based upon the requirements of the instant claims requiring engineering that increases binding at a low pH and high temperature compared to normal influenza A viruses.
Therefore, the most up-to-date knowledge of targeting influenza viruses to tumor tissue is not based upon the applicant's claimed mechanism. Furthermore, there is no prior art tool for detecting increased influenza virus binding to cell surfaces based upon hydrogen ion concentration and temperature, thus, there is no prior art demonstrating how to make modifications or use them as the applicant has claimed. Nowhere in the specification is there a detailed prophetic example of how to perform a comparative screening of wildtype and mutant influenza viruses under conditions of increased temperature and hydrogen ion concentration. Consequently, there is ample reason to conclude that there would be a high degree of unpredictability in a mammalian embodiment of the instant invention.
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 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “elevated” in claims 1, 5-8 is a relative term which renders the claim indefinite. The term “elevated” 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 term “elevated” in reference to body temperature and [H+] is relative to the cell environment and organism to which it pertains, thus without context surrounding the reference measurement “elevated” is indefinite.
The term “increased temperature” and “decreased pH” in claim 3 is a relative term which renders the claim indefinite. The term “increased temperature” and “decreased pH” 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 term “increased temperature” and “decreased pH” in reference to a zone immediate to a zone of hyperproliferating cells is relative to the cell environment and organism to which it pertains, thus without context surrounding the reference measurement “increased temperature” and “decreased pH” is indefinite.
Double Patenting
Claims 1-19 of this application is patentably indistinct from claims 1-19 of Application No. 17/671,552
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1-19 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-19 of copending Application No. 17/671,552 (reference application).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 17/881,382 (reference application) as evidenced by Li et al. (Bioengineered, 2013).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
Regarding claims 1 and 2, copending claim 1 preamble recites a method for directing production (engineering) of a vector designed to elicit a natural immune response (increase anti-viral immune response) to selectively attack cancerous (hyperproliferative) cells. Copending claim 1(a) and 1(b) recite selecting a first and second virus of the Orthomyxoviridae family (influenza “flu” virus is of this family of viruses) as the first and second vector. Copending claim 1(c) and 1(d) recite engineering said first virus to increase selective binding to a cell presenting with a temperature elevated in comparison to the cells producing said first virus to produce said first vector and engineering said second virus to increase selective binding to a cell presented in a pH depressed (elevated [H+]) in comparison to the cells producing said second virus to produce said second vector. Copending claim 4 recites a method for eliciting a natural immune response to selectively attack (infecting at least one) cancerous (hyperproliferative) cells while sparing normal, non-hyperproliferating cells, said method comprising: infusing said third vector of copending claim 1 into a human (introducing said virion into said body) to elicit a natural immune response (increase anti-viral immune response) to selectively attack cancerous cells while sparing normal, non-hyperproliferating cells.
The copending specification discloses on page 2, the invention features a virus, such as an influenza derived virus (line 1) and the “invention is enabled by vector engineering a flu virus” (line 6). The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ See MPEP § 804(II)(B)(1).
Li et al. define the influenza virus as a member of the family Orthomyxoviridae and outline the success in engineering influenza viral vectors (p. 9, Introduction, p. 12, Conclusions).
Thus, while the copending claims broadly claim a virus of the Orthomyxoviridae family, the invention requires the same “flu” virus as the instant claims.
Therefore, the copending claims 1 and 4 anticipate instant claims 1 and 2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/280,080 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
Regarding claim 1, copending claims 1, 4-5, and 17 recites a method for selectively attacking cancerous cells, which read as hyperproliferative cells as disclosed in copending claim 17. Copending claim 1 recites selecting a virus from the Orthomyxoviridae family, which includes influenza or “flu” viruses as disclosed in copending dependent claims 4 and 5.
Regarding claim 1a, copending claim 1c recites engineering a virus to increase selective binding to a cell presenting with an elevated temperature. Engineering a virus is broad to include culturing a virus. Therefore, copending claim 1c recites the limitations of instant claim 1a.
Regarding claim 1b, copending claim 1d recites engineering a virus to increase selective binding to a cell presented in a depressed pH. Depressed pH reads as elevated H+ concentration, therefore, copending claim 1d recites the limitations of instant claim 1b.
Regarding claim 1c, copending claim 1e recites co-culturing said first vector and said second vector to produce a third vector with increased selective binding to a cell presenting with a temperature elevated in comparison to the cells producing said first virus to produce said first vector and selective binding to a cell presented in a pH depressed in comparison to the cells producing said second vector. Said first vector is directed to the virus which favors elevated temperature, said second vector is directed to the virus which favors elevated H+ concentration, therefore, said third vector reads as continued engineering said flu virus to produce in culture a virion that favors both elevated temperature and elevated H+ concentration of instant claim 1c.
Regarding claim 1d, copending claim 1f recites presenting said third vector for infusion to selectively attack cancerous cells, this reads as introducing said virion into said body.
Regarding claim 2, copending claim 1 recites a method for eliciting a natural immune response to selectively attack cancerous cells. Eliciting a natural immune response reads as infecting at least one hyperproliferative cell.
Regarding claim 3, copending claim1 recites a method for eliciting an immune response in a hyperproliferative cell wherein the virus are engineered to target cells with increased temperature and H+ concentration.
Regarding claim 4, copending claim 13 recites the innate immune response recruits typical immune cells to attack the cancer cells. These immune cells would not be considered mutated towards a hyperproliferative metabolism and would be proximal to a zone of hyperproliferating cells.
Regarding claims 5 and 6, copending claim 1 recites the limitations of these claims.
Therefore, the copending claims 1-18 anticipate instant claims 1-6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631