Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claim Status
2. This Office Action is in response to the amendment filed 25 September 2023, wherein Applicant cancelled claims 1-51 and added new claims 52-66.
Claims 52-66 are under consideration.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 25 September 2023 and 04 September 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Drawings
4. The drawings are objected to because FIG. 5 and 6 do not have any labels. 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 Interpretation
5. According to ¶ [0115] of the specification of the PGPub of the Instant Application, a medium is “serum-free” when it has no additives from serum of human or animal origin and “protein-free” when multiplication of cells occurs with exclusion of proteins, growth factors, other protein additives, and non-serum proteins. “Protein-free” medium may include proteins or proteases that are necessary for viral growth.
Regarding claim 54, Examiner is interpreting that there is a total of 8 influenza gene segments and that the ratio (x:y) indicate that there are x segments from the first influenza virus (patient sample) and y segments from the second influenza virus.
Regarding claim 62, Examiner is interpreting that all growth, reassortment, and passaging do not occur in eggs.
It is noted that any interpretation of the claims set forth does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 52-66 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 52 recites the limitation "the MDCK cell line" in line 7. There is insufficient antecedent basis for this limitation in the claim. Thus, it is not clear if these are the same as in step a) or not. Multiple interpretations render the claims indefinite. Claim 52 recites the limitation "the infected cell line from step (a)" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting that one MDCK cell line is being infected with both viruses.
Claims 53-66, which depend on claim 52, are similarly rejected for all the above reasons.
The term “non-tumorigenic” in claims 64 and 66 renders the claim indefinite. The term “non-tumorigenic” 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. There is a variable ability to generate tumors. For example, the MDCK cells may be considered non-tumorigenic when injected into immunocompromised mice, wild-type mice, or grown in a flask, etc. Multiple interpretations render the claims indefinite.
Regarding claim 65, it is unclear if this is referring to the MDCK cell before or after the influenza viruses are added. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Regarding claims 52, 62-63, and 66, it is unclear if the terms “grown”, “growth”, and “growing” mean that the MDCK cells are increasing in size, dividing, or simply surviving. Examiner is interpreting these terms to mean that the MDCK cells are simply surviving.
Claims 53-66, which depend on claim 52, are similarly rejected.
8. 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.
9. Claims 64 and 66 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 following quotation from MPEP § 2163 is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice .... reduction to drawings .... or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Therefore, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 64 and 66 are rejected as lacking adequate descriptive support for a serum-free suspension culture of non-tumorigenic MDCK cells. In support of the claimed genus, the application discloses separate examples for MDCK cells that can grow in serum-free suspension culture and non-tumorigenic MDCK cells (¶ [0071] and [0072] of the PGPub, respectively). No derivatives or variants or mutants thereof are disclosed that can achieve both limitations. Thus, the application fails to provide examples of any species within the claimed genus.
The teachings of the art also fail to indicate that, without such evidence, those in the art would have expected the full scope of the claimed invention. For example, a search of the art indicates that MDCK cell lines have been found to produce tumors (Webster (see below), page 3, line 16). Additionally, Schwartz (WO 2006071563 A2; published 06 July 2006) (See IDS filed 25 September 2023) teaches that “it has been reported that there is correlation between the loss of anchorage requirement and the transformation of normal animal cells to cells which are tumorigenic” (¶ [0007]). Schwartz also teaches the non-tumorigenic MDCK cell lines that are disclosed in the Instant Specification and that “The present invention provides novel MDCK-derived adherent non-tumorigenic cell lines that can be grown in the presence or absence of serum.” (Abstract). This result contradicts the claimed functional characteristic that the non-tumorigenic cells are in suspension culture. In addition, the term “non-tumorigenic” is not defined in the specification and could read on multiple embodiments, for example, not causing tumors in immunocompromised mice, wild-type mice, in culture, etc.
Thus, in view of the above, there would have been significant uncertainty that Applicant possessed non-tumorigenic MDCK cells growable in serum-free suspension culture. In view of this uncertainty and the lack of any examples of the claimed genus, the claims are rejected for lack of adequate written description.
Claim Rejections - 35 USC § 103
10. 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.
11. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
12. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
13. Claims 52-57, 59, 61-62, and 64-66 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Webster (WO 9738094 A1; 16 October 1997) (See IDS filed 04 September 2025). In view of Groener (WO 9737000 A1; 09 October 1997) (See IDS filed 25 September 2025).
Regarding claim 52, it is noted that the limitations in the preamble are not given patentable weight. “A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).” Therefore, “for vaccine manufacture” recites intended use and does not hold patentable weight.
Webster teaches a method of creating reassorted mammalian influenza viruses: “The clinical isolates are preferably reassorted with laboratory high growth master donor strains in culture, and the reassortants selected that have HA and NA genes from the isolates, and internal genes from the high growth master laboratory strains. For example, the resulting strain for the influenza A component can be a reassortant virus that contains internal genes from the master donor strain A/PR 8/34 (H1N1), which provides high growth in host cells, as well as at least the HA gene coding for at least one surface antigen of the clinical isolate of the influenza virus” (Page 8, ¶ 2) and “Influenza A viruses were isolated from the throat washings of patients with clinical signs of influenza and collected in PBS to which 0.7% BSA was added. Cell cultures (both Vero and MDCK)… were infected directly with freshly collected (not frozen) throat washings.” (Example 2, Page 17, ¶ 3). This example does not explicitly state that the MDCK cells are then infected with A/PR/8/34. However, it would have been obvious to do so as Webster teaches reassorting the clinical isolates with master laboratory strains, in which A/PR/8/34 is given as an example, as discussed above. One of ordinary skill would know that co-infection of two viruses in a host (in this case, a MDCK cell) would result in a reassorted virus. In summary, Webster teaches isolating a first influenza virus strain from a patient sample, incubating it in an MDCK cell, and adding a laboratory strain to produce a reassorted influenza A virus. Webster also teaches that the hemaaglutinin and neuraminidase segments are from the patient sample, while the rest of the internal genes are from the laboratory strain, thus producing a reassortant that has segments in a 2:6 ratio. Webster does not teach MDCK cells that are grown in a serum-free suspension culture. However, Groener teaches “The cell line MDCK 33016 is derived from the cell line MDCK by passaging and selection with respect to the capability of growing in suspension in serum-free medium and of replicating various viruses … On account of these properties, these cells are suitable for economical replication of influenza viruses in cell culture by means of a simple and cost-effective process.” (Page 5, ¶ 2).
Therefore, it would have been obvious to one of ordinary skill before invention by Applicant to substitute the MDCK cell line of Webster for the MDCK 33016 cell line of Groener. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). One of ordinary skill in the art would have had a reasonable expectation of success for substituting one known MDCK cell line for another. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Neither Webster nor Groener teaches the limitation “seed virus”. However, since they both teach their methods for influenza virus vaccine development and the goal of the method of the art matches that of the claims, it would result in a seed virus. Any differences in the viruses of the claims and the methods used to make them are simply semantics. Claims 53-54, 56-57, 59, and 61 are encompassed in the teachings above and are thus similarly rejected.
Regarding claim 55, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. Therefore, this claim reads on the obvious method of claim 54 and is rejected for the same reasons as discussed above. Even if the wherein clause were given weight, it would necessarily occur since all steps required by the claim are found in the obvious method.
Regarding claim 62, Webster does not teach any steps that would require eggs during the production of the reassortant virus in MDCK cells. Thus, manufacture without the negative limitation of the claim is obvious.
Regarding claims 64, MDCK 33016 is non-tumorigenic in wild-type mice as such mice would destroy the heterologous cells. Regarding claims 65-66, Groener does not teach MDCK 33016 as requiring an overlay medium and so a method with the negative limitation of this claim is obvious for the reasons above.
14. Claim 58 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Webster (Supra) and Groener (Supra) as applied to claims 52-57, 59, 61, and 64-66 above, and further in view of Anderson (J. Clin. Microbiol., September 1992, 30(9): 2230-2234).
Regarding claim 58, the combination of Webster and Groener renders claim 52 obvious for the reasons supra. Claim 58 depends on claim 52 but requires the production of a reassortant influenza B virus. Webster further teaches “MDCK cells were infected with the throat cultures of patients with clinical signs of influenza. Only samples that were positive for influenza virus by indirect immunofluorescence test or by previous isolation in … MDCK cells were used. Infected cells were incubated for 72-96 hr. postinfection at 33 °C (for influenza B viruses)…” (Page 21, ¶ 3) and “MDCK cells were infected with either A/England/1/53 (HINl) or B/Ann Arbor/1/86…” (Page 21, ¶ 5). Webster does not teach the methods for producing a specific reassorted influenza B virus. However, Anderson teaches “The vaccine was derived by H. F. Maassab at the University of Michigan by crossing influenza B/Ann Arbor/1/66 ca virus with wild-type influenza B/Texas/84 virus. The clone which was selected exhibited the ca property and contained the six internal genes of influenza B/Ann Arbor/1/66 virus but possessed the hemagglutinin and neuraminidase genes of influenza B/Texas/84 virus. The resulting vaccine virus was designated influenza B/Texas/84 ca reassortant virus or CRB-87.” (Materials and Methods, ¶ 1). One of ordinary skill would be able to equate the wild-type virus to a strain isolated from a patient. Webster teaches that influenza B strains can be grown in MDCK cells and as an example, B/Ann Arbor/1/86, which is the same strain taught by Anderson.
Therefore, it would have been obvious to one of ordinary skill before invention by Applicant to take the obvious method of Webster and Groener and instead of applying them to A/PR/8/34 and a clinical isolate of influenza A, apply them to influenza B viruses to arrive at a reassorted influenza B strain with the NA and HA segments from the patient isolated sample and the six internal genes from the second influenza virus strain. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). One of ordinary skill in the art would have had a reasonable expectation of success for applying the methods of Webster and Groener to influenza B viruses. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
15. Claim 60 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Webster (Supra), Groener (Supra), and Anderson (Supra) as applied to claim 58 above, and further in view of de Wit (Virus Research, July 2004, 103(1-2): 155-161).
Regarding claim 60, the combination of Webster and Groener renders claim 57 obvious. Claim 60 depends on claim 57 but limits the number of segments of shared segments to PR/8/34 up to five. Webster nor Groener teaches using a specific different influenza A strain as the second strain. However, de Wit teaches using A/PR/8/34 and A/WSN/33 in a reverse genetics system to produce reassorted influenza viruses in MDCK cells, as well as the nucleotide and amino acid substitutions between MDCK-adapted A/PR/8/34 and those of A/PR/8/34 and A/WSN/33:
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Although de Wit does not explicitly teach incubating A/WSN/33 with another influenza strain in MDCK cells, they compare the pre-existing A/WSN/33 reverse genetics system to their newly-developed A/PR/8/34 reverse genetics system. Therefore, the two viral strains should be comparable in both mechanism and their ability to reassort, and it would be obvious to substitute A/WSN/33 for A/PR/8/34. Since A/PR/8/34 and A/WSN/33 do not share the same number of substitutions, they do not share any exact gene segments. Therefore, it would have been obvious to one of ordinary skill before invention by Applicant to take the obvious method of Webster and Groener and use A/WSN/33 instead of A/PR/8/34 as the secondary virus, as Webster merely gives an example of an influenza A strain to use. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). One of ordinary skill in the art would have had a reasonable expectation of success for applying the methods of Webster and Groener to a different influenza A virus. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
16. Claim 63 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Webster (Supra), Groener (Supra), Anderson (Supra), and Wit (Supra) as applied to claim 60 above, and further in view of Ge (PNAS, 19 February 2003, 100(5): 2718-2723), Moore (TCA Manual, 1977, 3(1): 503-509), and Mackenson (Cancer Immunol. Immunother., 2000, 49: 152-156).
Regarding claim 63, the combination of Webster and Groener renders claim 52 obvious. Claim 63 depends on claim 52, but further requires the medium to be protein-free. Neither Webster nor Groener teaches a protein-free medium. However, Ge teaches “MDCK cells were grown in DMEM containing 10% heat-inactivated FCS, 2 mM l-glutamine, 100 units/ml penicillin, and 100 μg/ml streptomycin at 37°C under a 5% CO2/95% air atmosphere. For siRNA introduction, logarithmic-phase MDCK cells were trypsinized, washed, and resuspended in serum-free RPMI medium 1640 at 2 × 107 cells per ml.” (Cell Culture and Virus Infection). As stated previously, “growing” in culture can simply mean surviving, and not necessarily dividing or increasing in size. Therefore, it would have been obvious that the MDCK cells were surviving in the RPMI 1640 media as the cells needed to be alive for siRNA introduction. Regarding the serum-free RPMI 1640 medium, Moore teaches the original composition (pages 504-505), which contains no protein:
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Therefore, it would have been obvious to one of ordinary skill before invention by Applicant to use the RPMI 1640 medium to grow the MDCK cells of Webster and Groener, at least momentarily. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). One of ordinary skill in the art would have had a reasonable expectation of success for substituting the media of Webster and Groener for serum-free RPMI 1640 medium. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
In addition, Mackenson teaches “The demonstration of IgE, IgG, and IgM antibodies to BSA in our patients after vaccination with peptide-pulsed DC suggests that the washing procedures and and final incubation of cells in PBS were inadequate to remove xenogeneic proteins from the DC. With the increasing use of ex vivo cultured cell preparations like DC, lymphocytes and irradiated tumor cells for immunotherapeutic approaches, it is critical to minimize an immune response to xenogeneic proteins, either by appropriate serum-free media or autologous serum/plasma.” (Discussion, ¶ 5). If there are proteins in the media, then they can be subject to an immune response during vaccination. Therefore, the amount of protein in a medium is a result-effective variable and should be minimized, such is the case when using RPMI 1640. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
Conclusion
17. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671