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 .
DETAILED ACTION
The amendment filed July 10, 2026 in response to the Office Action of May 20, 2026 is acknowledged and has been entered.
Claims 3, 13, and 14 have been amended.
Claims 1, 2, and 10-12 have been cancelled.
Claims 21 and 22 have been added.
Claims 3, 13-15, and 21-22 are pending.
It is noted that the prior art does not teach the isolated recombinant human T cells comprising:
(a) a TCRA gene encoding SEQ ID NO: 10 and a TCRB gene encoding SEQ ID NO:11;
(b) a TCRA gene encoding SEQ ID NO:12 or SEQ ID NO:13 and a TCRB gene encoding SEQ ID NO: 14;
(c) a TCRA gene encoding SEQ ID NO: 15 and a TCRB gene encoding SEQ ID NO:16; or
(d) a TCRA gene encoding SEQ ID NO:17 and a TCRB gene encoding SEQ ID NO:18.
Thus, claims 3 and 21 are drawn allowable subject matter.
Pursuant to the procedures set forth in MPEP § 821.04(B), claims 13-15, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement for Invention I and Invention II as set forth in the Office Action mailed on December 2, 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Accordingly, claims 3, 13-15, and 21-22 are pending and under consideration.
In view of cancellation of claim 10, the claim objections set forth in the previous Office Action of May 20, 2026 is hereby withdrawn.
In view of cancellation of claims 10-12, the 112(b) set forth in the previous Office Action of May 20, 2026 is hereby withdrawn.
In view of cancellation of claims 1, 2 and 4, the 112(a) (Scope of Enablement) rejection set forth in the previous Office Action of May 20, 2026 is hereby withdrawn.
In view of cancellation of claims 10-12, the 112(a) (Written Description) rejection set forth in the previous Office Action of May 20, 2026 is hereby withdrawn.
In view of cancellation of claims 10-12, the 103 rejection set forth in the previous Office Action of May 20, 2026 is hereby withdrawn.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. §1.56).
NEW REJECTIONS
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 13-15 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
“a method of treating a human for a cancer caused by human papilloma virus 16 (HPV 16) comprising administering to a human afflicted with a cancer caused by human papilloma virus 16 (HPV 16) the isolated recombinant human T cells of claim 3”,
does not reasonably provide enablement for:
“a method of treating a human for a cancer caused by human papilloma virus (HPV) or other disease caused by HPV comprising administering to a human afflicted with a cancer caused by HPV or other disease caused by HPV the isolated recombinant human T cells of claim 3”.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. This is a SCOPE OF ENABLEMENT rejection.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir.,1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547, the court recited eight factors to consider when assessing whether or not a disclosure would require undue experimentation. These factors are:
1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention 5) the state of the art, 6) the relative skill of those in the art, 7) the predictability of the art and 8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108,427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
Nature of invention and breadth of the claims:
The claims are drawn to a method for treating cancer caused by human papilloma virus (HPV) or other diseases caused by HPV, the method comprising administering the isolated recombinant human T cells of claim 3.
Given Broadest Reasonable Interpretation (BRI), the claim encompasses: a broad genus of cancers and diseases (all possible diseases) caused by a broad genus of HPVs (all types of HPVs).
Relative skill in the art:
The relative skill of those in the art is high with an MD or a PhD.
Level of unpredictability in the art and State of the prior art:
Regarding the broad genus of “HPV” and “HPV-related cancers”, Szymonowicz (Szymonowicz and Chen, Cancer Biol Med, vol. 17, No.4, 864-878, Publication Date: November, 2020) teaches that there are over 200 HPV types and the virus are highly tissue-specific (the bridging paragraph of pages 865-866). Many HPVs can cause various cancers including vulva, vagina, oropharynx, cervix, and anus cancers (Fig. 2B). Different cancers could have different origins, different drivers, and/or different microenvironments, thus, different cancers could have different responses to a cancer therapy. For example, vaccines, which protect against HPV 16 and 18, are not protective against other types of HPV (page 867, col. 2, para. 2). HPV-positive HNC (head and neck cancer) can include oral cavity, larynx, pharynx, paranasal sinuses, and nasal cavity and salivary glands, so the symptoms can vary (page 868, col. 1, para. 2). Treatments for HNCs may vary depends on the type and location of the HNC (page 868, col. 2, para. 2). Szymonowicz teaches that as the viral oncoproteins, E6 and E7, are crucial in HPV-mediated tumorigenesis (page 873, col. 2, para. 2); and different functional aspects of E6 and E7 in tumors infected with different HPV types (page 872, col. 2, para. 1).
Furthermore, Lizano (Lizano et al., Archives of Medical Research 40 (2009) 428-434, Publication Year: 2009) teaches HPV constitutes a diverse group of small DNA virus. A surprisingly large number of different HPV types have been identified and classified (>100) (Abstract). Viral types are cell-type specific and usually produce different kind of lesions, benign or malignant. Even HPV intratype variants may differ in biological behavior (Abstract). There are high-risk HPVs including HPV16, HPV33, HPV35 (page 431, § Epidemiological Classification of HPV Types). Biochemical properties of E6 and E7 proteins differ from high- and low-risk HPV types in a manner consistent with disease association (page 431, col. 1, para. 7).
In view of above, as evidenced by Examples of the instant Specification, the isolated recombinant human T cells of claim 3 are specific to the HPV 16, E6 protein, 91-115 amino acid region ([0054] and [0055]). One of ordinary skilled in the art would not expect that all HPV-related cancers/diseases can be treated with the isolated recombinant human T cells of claim 3.
Direction or guidance and working examples:
The specification only discloses a few recombinant T cells (see Fig. 9 and Table 3), which are specific to the HPV 16, E6 protein, 91-115 amino acid region ([0054] and [0055]). No therapeutic activity has been shown by the Examples. Thus, the working example does not support the scope of the claims, which encompass unlimited diseases (including cancers) caused by unlimited HPVs.
The quantity of experimentation needed:
The factors outlined in In Re Wands' mentioned above apply here, and in particular as per the MPEP 2164.01 (a): "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." It is very clear that one could not make/use this very broad invention that has no working examples in this unpredictable art without undue experimentation. Genetech Inc vs Nova Nordisk 42 USPQ 2d 1001 "A patent is not a hunting license. It is not a reward for search but compensation for its successful conclusion and patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Given the numerous unspecified cancers and other diseases encompassed by claim 13, the lack of specific guidance and the insufficient working examples, undue experimentation would be required of one of skilled in the art to produce the invention commensurate with the scope of the method as claimed.
Conclusion
Claims 3 and 21 are drawn to allowable subject matters.
Claims 13-15 and 22 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/ Supervisory Patent Examiner, Art Unit 1642
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