DETAILED ACTION
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 .
Claims Status
Claim(s) 1-19 is/are currently pending and presented for examination on the merits.
Claim Objections
Claim 1 (and dependent claims 2-5, 12) is objected to because of the following informalities: for clarity, “represented by” in lines 2- 6, 8-12, 14-18, 20-24, 26-30, 32-36, and 38-42 should be "comprising". Appropriate correction is required.
Claim 2 (and dependent claims 18-19) is objected to because of the following informalities: for clarity, “represented by” in lines 2-3, 5-6, 8-9, 11-12, 14-15, 17-18, and 20-21 should be "comprising". Appropriate correction is required.
Claim 5 is objected to because of the following informalities: for clarity, "A recombinant cell producing the antibody or fragment thereof specifically binding to CD47 or a fragment thereof transformed with the vector of claim 4” should be “"A recombinant cell comprising the vector of claim 4.”. Appropriate correction is required.
Claim 6 (and dependent claims 7-11, 15-17) is objected to because of the following informalities: for clarity, “represented by” in lines 5-9, 11-15, 17-21, 23-27, 29-33, 35-39, and 41-45 should be “"comprising". Appropriate correction is required.
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 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.
Claim(s) 4, 19 is/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 4 recites the limitation "the polynucleotide" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution, claim 4 is considered to depend from claim 3. This rejection may be overcome by amending claim 4 to depend from claim 3.
Claim 19 recites the limitation "the polynucleotide" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of compact prosecution, claim 19 is considered to depend from claim 18. This rejection may be overcome by amending claim 19 to depend from claim 18.
Claim Rejections - 35 USC § 112(a)
Claim(s) 13 is/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 CD47 expressing cancer or tumor comprising administering to a subject in need thereof an anti-CD47 antibody, does not reasonably provide enablement for a method of preventing a C47 expressing cancer or tumor comprising administering to a subject in need thereof an anti-CD47 antibody . 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.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation."' (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (A) The nature of the invention; (B) The breadth of the claims; (C) The amount of direction provided by the inventor; (D) The existence of working examples; (E) The state of the prior art; (F) The level of predictability in the art; (G) The quantity of experimentation needed to make or use the invention based on the content of the disclosure and (H) The level of one of ordinary skill. While all of these factors are considered, a sufficient amount for amount for a prima facie case are discussed below.
The nature of the invention
Claim(s) 13 is/are drawn to a method for preventing or treating a cancer or tumor expressing CD47 comprising administration of an anti-CD47 antibody.
The breadth of the claims
The claim is broad in that it encompasses the prevention of the recurrence of all CD47+ cancers.
The instant does not define the term ‘preventing’.
As the instant disclosure does not define the term “preventing”, the ordinary meaning prevent, “to keep from happening or existing”, as defined by Merriam-Webster (Dictionary webpage, 24 Apr 2025) is applied.
The claim is inclusive of all types of CD47+ cancers (e.g., brain cancer, breast cancer, colon cancer, uterine cancer, lung cancer, NHLs, Hodgkin’s lymphomas, CLL, MM, ALL, AML, MDS, MPNs, T cell lymphocytic leukemia, T cell large granular lymphoblastic lymphoma, NK cell leukemia, etc.). The breadth of the claim exacerbates the complex nature of the subject matter to which the instant claims are directed. Cancer is not a single disease, or cluster of closely related disorders. For example, in the just the subtype of hematological cancer are numerous unique cancers, which have some commonality (e.g., blood cell loss of controlled growth). However, despite the broad related grouping of ‘hematological cancers’, these diseases are heterogeneous at both the molecular and clinical level (e.g., myelomas, lymphomas, leukemias). Each type of hematological cancer also have subtypes with unique etiological and physiological characteristics. These differences are further confounded when including solid tumors versus hematological cancers.
The amount of direction provided by the inventor/the existence of working examples
The examples of the instant disclosure anti-CD47 agents include: confirming the binding ability of 7C7, SH4, SA4, 4E12, 3H3, 3AS and 1E7 targeting CD47 antibodies selected in the present invention to CD47-expressing tumor cells (MCF-7) by flow cytometry. [e.g., fig. 1]; schematic diagram illustrating a method for preparing CD47-CAR-expressing cells using the lentivirus expressing a chimeric antigen receptor (CD47-CAR) [e.g., fig. 2]; schematic diagram illustrating a method of confirming the binding ability of the transformed HEK293 cells to the CD47 peptide after transforming the HEK293 cell line with a CD47-CAR expression lentivirus vector [e.g., fig. 3]; data confirming CD47-CAR expression and binding ability to CD47 in 20 HEK293FT cells transformed with a lentivirus vector expressing CD47-CAR [e.g., fig. 4]; Preparation and selection of the antibody that specifically binds to CD47 [e.g., example 1]; Confirmation of specificity of the selected antibody for CD47 – ELISA analysis [e.g., example 2]; of specificity of the selected antibody for CD47 [e.g., example 3]; and CD47-CAR vector construction [e.g., example 4].
The examples provided do not demonstrate the prevention of cancers or tumors. Additionally, the disclosure does not discuss, or demonstrate through working examples, a method that could be used to determine that hematological tumors were prevented using claimed antibodies as there is no disclosed method to determine that tumor(s) would have predictably occurred without treatment.
The state of the art/the level of predictability in the art
There are no methods to establish that the occurrence of tumors or the suppression of recurrence of tumors can be prevented using the claimed therapeutic method in the prior art. Additionally, there are no methods that could be used to identify subjects who would have predictably developed tumors in order to determine that the tumors were prevented using the claimed methods.
One of ordinary skill in the art would understand that there are risk factors associated with certain cancers, and that an individual can lower their risk of cancer(s) but there is no sure way to prevent cancer, as evidenced by the American Cancer Society (Cancer Risk and Prevention webpage, 21 Mar 2025).
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Studies regarding the treatment and prevention of cancer are underway to improve early detection and provide better treatments. However, based on the instant disclosure and prior art, there is no known method through which one of ordinary skill in the art would have been able to reliably predict which subject(s) would have predictably developed tumors in order to determine that the tumors were prevented using the instant claimed methods. Therefore, in order to practice the invention as claimed, one of ordinary skill in the art would have to perform undue experimentation to develop a method which accurately predicts tumor prevention. Applicant is enabled for treatment of CD47+ cancers and tumors.
Conclusion
In view of the Wands factors as discussed above, one of ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the instant claimed invention. As such, instant claim 13 was determined to not meet the scope of enablement requirement of 35 USC § 112(a). Enablement can be met by amending claim 13 by removing the phrase “preventing or” in line 1.
Free From the Prior Art
During the course of examination, the anti-C47 antibody and CD47 directed CAR T cell antigen binding domains comprising the same antigen binding domain(s) comprising one of the seven claimed HCDR1-3 and/or LCDR1-3 sets (summary table provided below for ease of review), were found to nonobvious over the closest prior art. Briefly, a sequence search of the prior art returned no 100% matches to the instant claimed HCDR1-3 and/or LCDR1-3 for each of the seven claimed anti-CD47 antigen binding domains.
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Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643