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
Election/Restrictions
Claims are 7, 12, 14-15, 17, 22, 35, 38-39, 43-45, and new claims 66-68 are allowable. The restriction requirement between groups and species, as set forth in the Office action mailed on 11/17/2025, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 11/17/2025 is fully withdrawn. Claims 47-48, 56, 58, and 60, which are directed to various methods of treating, preventing, or alleviating a CLDN18 related disease and making an anti-CLDN18 antibody, are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a 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Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Claim Status
Claims 7, 12, 14-15, 17, 22, 35, 38-39, 43-45, 47-48, 56, 58, 60, and new claims 66-68 are pending.
Claims 7, 12, 14-15, 17, 22, 35, 38-39, 43-45, and 66-68 are allowable.
Claims 47-48, 56, 58, and 60 are rejected in the instant Office Action.
Withdrawn Objections
Rejections of claims 1, 4-7, 12, 14-15, 17, 22, 35, 38-39, and 43-45 due to minor informalities are hereby withdrawn in view of amendments to the claims.
Withdrawn Rejections
Rejections of claims 15, 17, and 22 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn in view of amendments to the claims.
Rejections of claims 1, 4-6, 12, 15, 17, 22, 35, 38-39, and 43-45 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 are hereby withdrawn in view of amendments to the claims.
Rejections of claims 1, 4-6, 12, 15, 17, 22, 35, 38-39, and 43-45 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the eighty seven fully disclosed anti-claudin 18 antibodies in the specification, does not reasonably provide enablement for all the potential CDRs identities of the antigen binding region that can arise from the substitutions and combinatorial language in the instant claims, are hereby withdrawn in view of amendments to the claims.
New Objections
Claims 47-48, 56, 58, and 60 are objected to because of the following informalities: the claims are grammatically incorrect, and the sentence structures are convoluted in listing out their limitations. The additional limitations recited in the claims do not read fluidly and instead obscure the meanings of the claims. Appropriate correction is required.
New Rejections
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 47-48, 56, 58, and 60 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.
With regards to instant claim 47, it is unclear what the method of expressing the antibody encompasses. The instant claim recites that the antibody will be “expressed”, followed by a limitation that simply describes a chimeric antigen receptor that is cultured in a host cell comprising a vector that is expressed. In addition to the claim not being grammatically correct, the wording of the claim does not ascertain whether the antibody is to be expressed in a similar manner as the chimeric antigen receptor, or if it is to be treated separately. Applicant is encouraged to amend the claims to clarify the methods in which expression is to occur.
With regards to instant claims 48, 56, 58, and 60, it is unclear if the methods encompass using the antibody or antigen-binding fragment of claim 7 separately, or with the chimeric antigen receptor comprising the antibody. The recitation of the limitations in the claims is unclear, and the broadest reasonable interpretation of these claims reads as stacking additional elements that are to be used in the method(s) without clarifying in detail the active steps that constitute how the method is to be conducted. Applicant has simply listed out all the possible products that can be used in the claimed method without explaining details as to how they are to be used.
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 48 and 56 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 or alleviating a CLDN18 related disease, does not reasonably provide enablement for preventing a CLDN18 related disease. 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 use the invention commensurate in scope with these claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The factors most relevant to this rejection are the amount of direction provided by the inventor and the existence of working examples. In the instant case, the amount of direction provided by the inventor and existence of working examples disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue experimentation.
The amount of direction provided by the inventor - The amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in preventing CLDN18 related diseases such as cancer, the skilled artisan would need significant guidance in preparing the invention as a preventative measure. The skilled artisan recognizes that preventing cancer is an intractable proposition, if not now wholly impossible, given, for example, that no specific cause of the cancer is claimed. It is generally recognized that a disease cannot be prevented unless and until its causes are fully appreciated and understood to a degree that it becomes possible to intercede effectively to block its onset or development by any cause.
The existence of working examples - As stated above the specification reasonably provides enablement for the antibodies with the recited sequences that treat CLDN18 related diseases such as gastric cancer. However, there is no showing in the specification of any means by which one skilled in the art could prepare a composition to prevent said cancers. The instant specification provides an enabling disclosure for treating cancer but does not do so for “treating” when treating is interpreted to encompass the prevention of cancer. Additionally, the state of the art does not clearly outline metrics or guidelines to predict an individual’s propensity to develop gastric cancer and prevent its onset or occurrence, thus making the target of the treatment unclear as it is impossible to know if a person in the general public will develop one of the diseases listed with certainty and also qualify as a candidate for treatment using the instant invention. Therefore, one skilled in the art would be subject to undue experimentation to practice the instant invention as it is currently claimed.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention, the amount of direction provided by the inventor and the working examples provided, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation.
Applicant is informed that the instant rejection under 35 U.S.C. 112 (a) may be overcome by amending the claims to remove the recitation of “preventing.”
Conclusion
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 SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SELAM BERHANE/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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