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 .
Status of Claims
Claims 1-20 are pending.
Priority
Claims 1-20 have priority to 371 of PCT/CN 2021/138535 filed on December 15, 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on June 17, 2024, was filed before the mailing of the First Office Action on June 13, 2026. The Non-Patent Literature is in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities for “wide type” found at:
Pg. 10 Line 7.
Pg. 13 Line 5, 7, and 24.
Pg. 14 Lines 1, 5, 8, 14, 33, 37, and 40.
Pg. 15 Lines 3, 22, 26, 34, and 38.
Pg. 18 Lines 10, 17, 24, and 30.
Pg. 19 Lines 27 and 28.
Should read as “wild type”. Appropriate correction is required.
Claim Objections
Claim 10 is objected to for the following reasons:
Claim 10 line 3 recites “as compared to a wide-type capsid protein” should read as “as compared to a wild [[wide]]-type capsid protein”. Appropriate correction is required.
Claim 10 line 4 recites “of the wide-type VP1” should read as “of the wild [[wide]]-type VP1”. Appropriate correction is required.
Claim 10 line 5 recites “of the wide type VP2” should read as “of the wild [[wide]]-type VP2”. Appropriate correction is required.
Claim 10 line 5 recites “of the wide-type VP3” should read as “of the wild [[wide]]-type VP3”. Appropriate correction is required.
Drawings
The drawings are objected to because:
Figs 1A, 1B, and 1C are not legible.
Figs. 2A, 2B, 2D, 2G, and 2I are not legible.
Figs. 3C and 3E are not legible.
Figs. 6A, 6B, and 6C are not legible.
Figs. 7A, 7B, 7C, and 7D are not legible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 12, 15, and 19-20 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112(pre-AIA ), first paragraph, as failing to comply with the 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 it is most nearly connected, to make and/or use the invention.
Nature of the Invention:
The claimed invention is directed to methods for treating neurological disorders by administering a therapeutically effective amount of a pharmaceutical composition comprising a recombinant AAV vector containing substituted amino acid regions in the capsid protein.
Breadth of the claims:
Claim 19 broadly recites a method for treating a neurological disorder by administering the pharmaceutical composition of claim 15. Claim 20 further expands the scope to encompass a group of neurological disorders that include Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, and others. Each of these conditions have distinct etiologies, pathological mechanisms, and therapeutic requirements.
Amount of direction or Guidance present in the Specification:
The specification provides only general statements regarding the association between microglial dysfunction and neurological disease, including that “emerging evidences have recognized microglial dysfunction as a key factor in CNS aging and in the progression of CNS diseases including neurological disorders and brain cancer” [Background ¶ 1]. The specification further states microglial interactions contribute to neurological disease pathology through inflammatory pathways [pg. 11 line 38]. The specification further states that, in some embodiments, the disclosed method may be used to treat neurological disorders that including diseases associated with microglial, and associated disorders [pg. 4 line 3]. However, the specification does not provide guidance as to disease specific therapeutic targets, selection of transgenes, dosing regimens, treatment protocols, biomarkers of efficacy, or mechanisms by which the claimed composition would achieve therapeutic benefit across the full scope of recited disease processes.
Presence of absence of Working Examples:
The specification lacks any working examples demonstrating treatment of any neurological disorder. The only in vivo experimental disclosure relates to microglial genome editing using an sgRNA targeting the microglial homeostatic marker gene P2ry12. However, this experiment does not employ any disease model, does not evaluate therapeutic efficacy, and does not demonstrate amelioration of any neurological disorder recited in claim 20 or any other neurological disorder.
Relative Skill in the Art:
It is argued that the relative skill in the art, is that of a scientist with several years’ experience in the field, but that the Art itself is a recognition of what is understood by the Artisan, and thus, as seen below, does not make the breadth of the claims more predictable.
Predictability or Lack thereof in the Art:
The art is not predictable. As discussed in Ataei et al., gene therapy for neurodegenerative diseases such as Alzheimer’s disease requires careful identification of disease-relevant molecular targets and optimized vector design [Introduction, A review of the advances, insights, and prospects of gene therapy for Alzheimer’s disease: a novel target for therapeutic medicine, Gene, 2024]. Additionally, Gao et al. discusses the complexity of microglia and that these cells are highly dynamic and context-dependent immune cells whose functional roles vary significantly across different neurological diseases and disease stages [Abstract, Microglia in neurodegenerative diseases: mechanism and potential therapeutic targets, Nature Signal Transduction and Targeted Therapy, 2023]. These references show that neurological diseases involve complex and distinct pathological mechanisms, and that microglial behavior varies substantially across disease states.
Quantity of Experimentation Needed:
A person of ordinary skill in the art would need to engage in extensive and iterative experimentation that would require identification of disease specific therapeutic targets, selection and validation of appropriate transgenes, development of disease relevant animal models, optimization of delivery parameters, and empirical confirmation of therapeutic efficacy for each recited neurological disorder. This amount of experimentation would be substantial and would be beyond routine optimization.
Conclusion:
Based on the above factors, the specification fails to provide sufficient disclosure to allow one or ordinary skill in the art to make and use the claimed invention as it pertains to claims 1, 12, 15, and 19-20 without undue experimentation.
Claims 1-4, 7-8, and 10-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for 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.
Claim 1 uses the generic language where it lists alternative amino acids for 11 contiguous amino acids X1X2X3X4X5X6X7X8X9X10Q where X1-X10 have multiple amino acids that can be substituted at each position. The same generic scope is present in each of the dependent claims, i.e. 2-4, 7-8, and 11-20.
The specification provides antecedent basis for alternative amino acids for 11 contiguous amino acids X1X2X3X4X5X6X7X8X9X10Q where X1-X10 have multiple amino acids [pg. 2 line 12].
Applicant’s specification describes generation of AAV9 capsid libraries through random heptamer insertion and semi-random mutagenesis, along with disclosing certain variants identified through in vitro and in vivo microglia screening [Fig. 1, pg. 15 line 40, pgs 13-15]. However, the specification only provides a limited number of specific capsid sequences and variants recovered from the selection process [Id.]. The specification does not disclose representative species spanning the full scope of the claimed genus. The specification also does not identify any structural features that are common to the entire genus that would allow a person of ordinary skill in the art to recognize what substitutions are viable and what substitutions are not given there are over one hundred thousand variations present in claim 1. The specification also does not disclose whether the undisclosed amino acid combinations recited in claim 1 would in fact retain the necessary characteristics associated with the disclosed variants, namely being capable of targeting microglia. The specification lists roughly 11 amino acid sequences with respect to VP1-VP3. Based on this, a person of ordinary skill would not be able to quantify what combinations would be viable alternatives than what is listed in Applicant’s specification given the limited number of disclosures compared to the total number of possible combinations based on claim 1’s language.
Given the generic scope of where it lists alternative amino acids for 11 contiguous amino acids X1X2X3X4X5X6X7X8X9X10Q where X1-X10 have multiple amino acids and the absence of teachings of what other combinations of amino acid substitutions based on claim 1’s language, an Artisan would not understand Applicant to be in possession of the full scope of the claimed genus of amino acid sequence substitutions.
Claims 1, 12, 15, and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for 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.
Claim 19 uses the generic phrase “a method for treating a neurological disorder” as it relates to administering a pharmaceutical composition of claim 15 that includes the recombinant AAV vector with the amino acid substituted capsid protein.
The specification provides antecedent basis for “a method for treating neurological disorder” [pg. 4 ¶ 2].
Applicant’s specification states “…another aspect of the present disclosure, provided is a method for treating a neurological disorder, which comprises administering a therapeutically effective amount of the pharmaceutical composition to a subject in need thereof” [pg. 4 ¶ 2]. The specification further states the neurological disorders comprise Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, and others [Id.]. In describing microglia, Applicant’s specification states microglia play a crucial role in healthy brain as regulators of synaptic functions and phagocytosis, in disease they play a crucial role in neurological and neuroinflammatory conditions coupled with their interactions with T cells [pg. 11 ¶ 5]. However, the specification provides no examples, no discussion, no in vivo or in vitro examples with respect to showing the claimed invention is capable of treating any of the listed neurological diseases, let alone any neurological disease or disorder. Furthermore, several studies have found that phagocytosis by microglia with respect to Aβ actually promoted plaque development [Gao et al., Microglial role in the pathogenesis of AD ¶ 1]. Given this and the uncertainty of how microglia interact in the listed disease processes, a person of ordinary skill in the art would not understand that Applicant was in possession of the claimed limitations given Applicant failed to provide any experimentation as it relates to the listed neurological disorders listed in claim 20 or any neurological disorder as it relates to microglia in general.
Given this and the generic phrase “a method for treating a neurological disorder” and the absence of any teachings of what or how a recombinant rAAV containing a substituted amino acid region in the capsid protein is capable of treating neurological disorders, an Artisan would not understand Applicant to be in possession of the claimed invention.
Claim Rejections - 35 USC § 112
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 10, 13, 17, and 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.
Claim 10 states “preferably inserted between amino acids…”. The phrase “preferably” is unclear given that it is unclear whether the limitation following the term “preferably” is part of the claimed invention. See MPEP §2173.05(d).
Claim 13 states “which preferably encodes a heterologous polypeptide”. The phrase “preferably” is unclear given that it is unclear whether the limitation following the term “preferably” is part of the claimed invention. See MPEP §2173.05(d).
Claim 17 line 2 states “preferably in the presence of an inhibitor”. The phrase “preferably” is unclear given that it is unclear whether the limitation following the term “preferably” is part of the claimed invention. See MPEP §2173.05(d).
Claims 17 line 3 states “wherein the inhibitor more preferably is selected”. The phrase “preferably” is unclear given that it is unclear whether the limitation following the term “preferably” is part of the claimed invention. See MPEP §2173.05(d).
Claim 19 states “preferably the neurological disorder is a disease associated with microglia”. The phrase “preferably” is unclear given that it is unclear whether the limitation following the term “preferably” is part of the claimed invention. See MPEP §2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-7, and 10-19 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Schaffer et al. [CN 109640949A, 2019].
Regarding claim 1, Schaffer et al. teaches a recombinant adeno-associated virus (rAAV) capsid protein [Summary of the Invention ¶ 1], comprising an amino acid sequence of 11 contiguous amino acids X1X2X3X4X5X6X7X8X9X10Q, wherein
X1 is selected from Ala or Leu;
X2 is selected from Gln, Met, Thr, Val or Pro;
X3 is selected from Trp, Thr, Glu, Pro, Leu, Ala or Gln;
X4 is selected from Pro, Thr, Met, Ser, Arg or Ala;
X5 is selected from Pro, Ser, Val, Asp or Phe;
X6 is selected from Lys or Pro;
X7 is selected from Thr or Arg;
X8 is selected from Thr, Glu or Pro;
X9 is selected from Ser, Pro or Ala; and
X10 is selected from Ala or Asp [Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”].
Regarding claim 2, Schaffer et al. teaches the rAAV capsid protein according to claim 1, wherein X6 is Lys; X7 is Thr; X8 is Thr; X9 is Ser; and/or X10 is Ala [Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”].
Regarding claim 3, Schaffer et al. teaches the rAAV capsid protein according to claim 2 where X1 is selected from Ala or Leu; X2 is selected from Gln, Met, Thr or Val; X3 is selected from Trp, Thr, Glu, Pro or Leu; X4 is selected from Pro, Thr, Met or Ser; and/or X5 is selected from Ser, Val, Asp or Pro [Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”].
Regarding claim 6, Schaffer et al. teaches the rAAV capsid protein according to claim 1, wherein X1 is Ala; X6 is Pro; and/or X7 is Arg [Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”].
Regarding claim 7, Schaffer et al. teaches the rAAV capsid protein according to claim 6, wherein X2 is selected from Gln or Pro; X3 is selected from Thr, Ala or Gln; X4 is selected from Arg or Ala; X5 is selected from Pro or Phe; X8 is selected from Glu or Pro; X9 is selected from Pro or Ala; and/or X10 is selected from Ala or Asp [Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”].
Regarding claim 10, Schaffer et al. teaches the rAAV capsid protein according to claim 1, wherein the amino acid sequence of 11 contiguous amino acids X1X2X3X4X5X6X7X8X9X10Q is inserted in a GH-loop as compared to a wide type capsid protein thereof, preferably inserted between amino acids 588 and 589 of the wide-type VP1, amino acids 451 and 452 of the wide type VP2 and/or amino acids 386 and 387 of the wide type VP3, of AAV9 or the corresponding position in the capsid protein of another AAV serotype than AAV9 [Para starting with “In some cases, from about 5 amino acids to about 20 amino acids relative to the corresponding”].
Regarding claim 11, Schaffer et al. teaches a polynucleotide sequence encoding the AAV capsid protein as defined in claim 1 [Para starting with “As used herein, “rAAV vector” refers to” and Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”].
Regarding claim 12, Schaffer et al. discloses a recombinant adeno-associated virus (rAAV) vector comprising the capsid protein as defined in claim 1 [Para starting with “As used herein, “rAAV vector” refers to” and Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”].
Regarding claim 13, Schaffer et al. discloses the rAAV vector according to claim 12, further comprising a heterologous polynucleotide sequence, which preferably encodes a heterologous polypeptide, a non-coding RNA or a CRISPR agent [Summary of the Invention ¶1].
Regarding claim 14, Schaffer et al. teaches the rAAV vector according to claim 13, wherein the heterologous polynucleotide sequence encodes miRNA, siRNA, piRNA, lncRNA, or a guide RNA [Para starting with “A “small interference” or “short interfering RNA” or siRNA”].
Regarding claim 15, Schaffer et al. teaches a pharmaceutical composition comprising the rAAV vector as defined in claim 12, and one or more pharmaceutically acceptable carriers [Pharmaceutical composition ¶ 1].
Regarding claim 16, Schaffer et al. teaches a method for delivering the rAAV vector as defined in claim 12 into a target cell, comprising contacting the target cell with the rAAV vector [Para starting with “An “infected” virus or virion is a virus”].
Regarding claim 18, Schaffer et al. teaches a host cell comprising the rAAV vector as defined in claim 12 [Nucleic acid and host cell ¶ 1].
Regarding claim 19, Schaffer et al. teaches a method for treating a neurological disorder, comprising administering a therapeutically effective amount of the pharmaceutical composition of claim 15 to a subject in need thereof, preferably the neurological disorder is a disease associated with microglia [Para starting with “The term “retinal cell” may be used” and Para starting with “An “infected” virus or virion is a virus”].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4, 8,17, and 20 are rejected under 35 U.S.C. §103 as being unpatentable over Schaffer et al. [CN 109640949A, 2019], in view of Rosario et al. [Microglia-specific targeting by novel capsid-modified AAV6 vectors, Molecular Therapy: Methods & Clinical Development, 2016], in view of Naumer et al. [Development and validation of novel AAV2 random libraries displaying peptides of diverse lengths and at diverse capsid positions, Human Gene Therapy, 2011], in view of Marsic et al. [US 2016 369298 A1].
Schaffer et al. teaches all the limitations for claims 1-3. However, Schaffer et al. does not disclose the specific combinations as listed in claim 4. However, Schaffer et al. does teach recombinant AAV capsid proteins in which specific amino acid positions are modified through substitution to generate capsid variants [Para starting with “X1X2X3X4X5X6X7X8X9X10, where:”]. In Addition, both Naumer et al. and Marsic et al. disclose combinatorial capsid engineering strategies where multiple capsid positions are simulataneously or independently mutated to produce recombinant AAV capsid protein variants [Abstract and ¶ [0005], Respectively]. Given this, a person of ordinary skill in the art would have understood that the amino acid positions recited in claim 4 are capable of routine substitution as part of a standard capsid library design practices, and that specific amino acid identities at positions X1-X5 would have been obtained through routine screening of such libraries to identify functional capsid variants. Because of this, there is a reasonable expectation of success that person of ordinary skill in the art to obtain rAAV capsid variants comprising the claimed amino acid substitutions at positions X1-X5 given the disclosures in Schaffer et al. combined with the teachings of both Naumer et al. and Marsic et al. where they disclose these positions can be routinely modified within capsid libraries using established strategies and that functional capsids are readily identified through standard screening.
Regarding claim 8, the same analysis as applied to claim 4 is applied to claim 8.
For claim 17 where the target cell is microglia in vitro or in vivo, Rosario et al. discloses that capsid-modified AAVs can efficiently target microglia in vitro resulting in microglia-specific expression of green fluorescent protein [Abstract].
For claim 20 where the neurological disorder targeted comprises Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, etc., Rosario et al. teaches that recombinant adeno-associated viruses have been used to target several neuropsychiatric disorders including Parkinson’s disease, Huntington’s disease, and amyotrophic lateral sclerosis [Introduction ¶ 1].
Here, it would have been prima facie obvious to a person skilled in the art prior to the filing of the claimed invention to modify the systems and methods of Schaffer et al. that disclosed a modified capsid protein with the additional teachings of both Naumer et al. and Marsic et al. where both disclose these positions can be routinely modified within capsid libraries using established strategies and that functional capsids are readily identified through standard screening with the additional teachings of Rosario et al. that discloses recombinant adeno-associated viruses have successfully targeted microglial cells and that these engineered adeno-associated viruses have been used in preclinical models for mediated gene targeting in several types of neuropsychiatric disorders that include Parkinson’s disease, Huntington’s disease, and amyotrophic lateral sclerosis, as well as other types of diseases. Given this, there is a reasonable expectation of success that a person of ordinary skill would recognize the teachings under Schaffer et al. and would combine it with general knowledge of amino acid substitution as taught by both Naumer et al. and Marsic et al. with the further teachings of Rosario et al. to engineer recombinant adeno-associated viruses with amino acid substituted capsid proteins in order to target microglia that are associated with neuropsychiatric disorders.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims Free of the Art
Claim 5 is free of the art. The art does not direct a skilled artisan to substitute the regions of VP1-VP3 with the amino acid sequences listed in claim 5.
Claim 9 is free of the art. The art does not direct a skilled artisan to substitute the regions of VP1-VP3 with the amino acid sequences listed in claim 9.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN DAVID MOORE whose telephone number is (703)756-1887. The examiner can normally be reached M-F 8-5.
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, Tracy Vivlemore can be reached on 571-272-2914. 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.
/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights