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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Feb. 17, 2025 has been entered.
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Feb. 17, 2025. Claims 19, 21-27 and 29-40 are pending and currently examined.
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.
(New Rejection – Necessitated by Amendment) Claims 19, 21-27 and 29-40 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 base claim 19 is amended to specify “wherein said antibody inhibits cell-to-cell spread when less than 20% of the adjacent cells are infected.” This limitation is not clear as to how the limitation “when less than 20% of the adjacent cells are infected” should be interpreted. E.g., it is not clear what should be used as the reference location to determine if a cell can be considered as adjacent, and under what condition the antibody inhibition of cell-to-cell spread is tested (e.g., what antibody titer is used, on what host cells, in vitro or in vivo, etc.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
(Previous Rejection – Maintained) Claims 19, 21-25, 29-30, 34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Haynes et al. (US 2014/0302062 A1, published on Oct. 9, 2014, PCT filed on April 9, 2012) in view of Betz (WO 2005/023303 A1, published on March 17, 2005) and/or Chen et al. (US 2011/0033389 A1, published on Feb. 10, 2011). This rejection is extended to new claims 38-40.
(Previous Rejection – Maintained) Claims 25-27 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Haynes et al. (US 2014/0302062 A1, published on Oct. 9, 2014, PCT filed on April 9, 2012), Betz (WO 2005/023303 A1, published on March 17, 2005), and/or Chen et al. (US 2011/0033389 A1, published on Feb. 10, 2011), as applied above, in view of Krawczyk et al. (PNAS, 110(17): 6760–6765, April 23, 2013; submitted in IDS filed on Feb. 18, 2022) and/or Roggendorf et al. (US 2013/0058952 A1, published on Mar. 7, 2013).
Applicant argues that on page 11 of the Final Office action, the examiner suggested that this additional language (i.e., specifying the extent the inhibiting capability should be) would distinguish the cited art, as the art fails to teach or suggest all of the elements recited in the amended claims. Applicant argues that, specifically, the cited art does not teach a topical HSV treatment method using a neutralizing full-length monoclonal anti-HSV antibody capable of inhibiting cell-to-cell spread when less than 20% of the adjacent cells are infected.
Applicant’s arguments are not persuasive. No suggestion can be found in the Final Office Action that the added language in the amendment claims would distinguish the cited art. On the contrary, on page 11 of the Final Office action, it is stated that the Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the Mab hu2c of Krawczyk et al. does not possess the structure required by these claims. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed antibodies are different from that taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Here, the newly added limitation is vague (see 112(b) above). The antibodies disclosed in the cited rejections are expected to be effective in the treatment of HSV infections by topical administration. Therefore, it is reasonable to expect that the antibodies of the cited references will have the effect as claimed, including the effect of inhibiting cell-to-cell spread when less than 20% of the adjacent cells are infected.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JANET ANDRES, on (571) 272-0867, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/ Primary Examiner, Art Unit 1671