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
Claims 2, 4-20, and 22-25 are pending.
Claim 25 is newly added.
Claims 2, 5, 6, 9, and 13 are currently amended.
Claim 2 is allowable. Claims 14-16, 19, 20, and 24, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions I-III, as set forth in the Office action mailed on 06/24/2025, is hereby withdrawn and claims 14-16, 19, 20, and 24 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are 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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Claims 2, 4-20, and 22-25 are under examination on the merits.
Rejections Withdrawn
35 U.S.C. 112(d)
The rejection of claim 9 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, is withdrawn in view of the amendments to the claim, dated 12/23/2025.
35 U.S.C. 112(a)
The rejection of claims 2, 5-7, 9-13, 17, 18, 22, and 23 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in view of the amendments to the claim, dated 12/23/2025.
Claim Rejections
35 U.S.C. 112(b)
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.
Claim 8 is 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.
Regarding claim 8, the phrase “optionally” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
35 U.S.C. 112(a)
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 19, 20, and 24 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 is drawn to a method for treating or preventing cancer, comprising administering to an individual an effective amount of an anti-CD47 antibody or antigen-binding fragment thereof. It is initially noted that there would be no expectation that an anti-CD47 antibody or antigen-binding fragment thereof is capable of treating a cancer that does not express CD47, and the specification does not provide any examples of an anti-CD47 antibody or antigen-binding fragment thereof that is capable of treating a cancer that does not express CD47. Following a review of the specification it appears that there are examples demonstrating the effectiveness of an anti-CD47 antibody or antigen-binding fragment thereof in treating CD47-expressing cancers, and as such the specification provides support for a method of treating a CD47-expressing cancer by administering an anti-CD47 antibody or antigen-binding fragment thereof to an individual in need thereof.
This rejection may be overcome by amending claim 19 to recite a method of treating a CD47-expressing cancer.
Claims 19, 20, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Claim 19 is drawn to a method for treating or preventing cancer, comprising administering to an individual an effective amount of an anti-CD47 antibody or antigen-binding fragment thereof. Although the specification is enabled for treating cancer by administering an anti-CD47 antibody or antigen-binding fragment thereof, the specification is not enabled for preventing cancer by administering an anti-CD47 antibody or antigen-binding fragment thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to 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 1) the amount of direction provided by the inventor and 2) 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.
(1) 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 the area of disease prevention, particularly cancer prevention, the skilled artisan would need significant guidance in preventing cancer by practicing the claimed method. The skilled artisan recognizes that keeping individuals free of cancer indefinitely is an intractable proposition, if not now wholly impossible, given, for example, that cancers are widely heterogeneous diseases, having widely varying pathologies and etiologies, and with causes that are multifactorial and as yet only partially characterized and poorly understood. 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.
(2) The existence of working examples - The examples of the specification demonstrate methods that may be used to treat cancer by administering an anti-CD47 antibody or antigen-binding fragment thereof; however there is no showing in the specification of any means by which one skilled in the art could prevent cancer by administering an anti-CD47 antibody or antigen-binding fragment thereof. 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 this rejection may be overcome by amending claim 19 to remove the recitation of “preventing.”
Further at issue is the following two paragraphs from p. 22 and 23 of the specification, which state the following:
As used herein, “treatment” includes 1) therapeutic measures, which cure, alleviate and relieve the symptoms of the diagnosed pathological condition or disease and/or stop the progress of the diagnosed pathological condition or disease, and 2) preventive or prophylactic measures, which prevent and/or alleviate the development of the pathological condition or disease. Therefore, the subject receiving the treatment include an individual who has suffered from the disease, an individual who is prone to suffer from the disease, and an individual who wants to prevent the disease. In some embodiments, the present invention relates to the treatment of a disease or condition. In some other embodiments, the present invention relates to the prevention of a disease or condition.
In some embodiments according to the present invention, the “treatment” of a disease or condition refers to the improvement of the disease or condition (i.e., alleviating or preventing or reducing the progression of the disease or at least one of its clinical symptoms). In some other embodiments, “treatment” refers to relieving or improving at least one body parameter, including those physical parameters that may not be discernible 10 by the patient. In some other embodiments, “treatment” refers to the regulation of a disease or condition physically (e.g., stabilization of discernible symptoms), physiologically (e.g., stabilization of body parameters), or both. Methods for evaluating the treatment and/or prevention of a disease are generally known in the art unless explicitly described herein.
This passage defines the term “treatment” as encompassing “prevention,” and as indicated above, although the specification is enabled for treating cancer by administering an anti-CD47 antibody or antigen-binding fragment thereof, the specification is not enabled for preventing cancer by administering an anti-CD47 antibody or antigen-binding fragment thereof. Given that the specification is not enabled for methods of preventing cancer, Applicant is encouraged to amend the specification such that the term “treatment” does not encompass “prevention.” The issues with the above passage may be overcome by amending the specification as follows:
As used herein, “treatment” includes s an individual who has suffered from the disease
In some embodiments according to the present invention, the “treatment” of a disease or condition refers to the improvement of the disease or condition (i.e., alleviating or preventing or reducing the progression of the disease or at least one of its clinical symptoms). In some other embodiments, “treatment” refers to relieving or improving at least one body parameter, including those physical parameters that may not be discernible 10 by the patient. In some other embodiments, “treatment” refers to the regulation of a disease or condition physically (e.g., stabilization of discernible symptoms), physiologically (e.g., stabilization of body parameters), or both. Methods for evaluating the treatment
Conclusion
Claims 2, 4-17, 22, 23, and 25 are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F 9:00 am - 6:00 pm EST
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on 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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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642