DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 17, 2025 has been entered.
3. Claims 11, 12, 16 and 17 are pending.
Claims 13-15 have been cancelled.
Claims 11 and 12 have been amended.
Claims 16 and 17 have been added.
Claims 11, 12, 16 and 17 are examined on the merits.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
5. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112, 1st as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The wherein clause reading on the co-administered additional therapeutic agent is not a tumor-specific antibody, which was formerly listed in the last line of claim 11 has been deleted.
However, Applicant has currently amended claim 11 and added claim 16 state the “…method for treating hepatocellular carcinoma or a melanoma,… comprising… a pharmaceutical composition comprising…the sole active ingredient of the pharmaceutical composition…”, see Amendments to the Claims submitted December 4, 2025. And while Applicant asserts support for this limitation can be at least found in the Specification as filed on page 19, lines 15 to 21, that segment in brief reads, “In this stringent model, we observed that anti-SIRPa monoclonal antibody treatment in monotherapy significantly protected mice with an efficacy similar to Sorafenib.”, see lines 19-21. Also of record in the Specification states “[t]he in vivo experiments on 2 different cancer models showed that SIRPa is an interesting target for cancer treatment as monotherapy and even more when combined with other immunotherapies or chemotherapy.”, see page 20, lines 14-16.
This limitation, “…sole active ingredient of the pharmaceutical composition…” is not of record in the instant application, nor the application from which the claimed invention requests priority. Giving the term, monotherapy the broadest reasonable interpretation and as inferred on page 20, one given therapeutic agent does not mean additional therapeutic agents are not administered. And sole active ingredient does not mean additional ingredients are not within the pharmaceutical composition, but it is the only ingredient that achieves the intended effect and/or performs the desired function. Monotherapy and sole active ingredient are not one and the same, hence the new limitation reading on sole active ingredient is regarded as new matter. Applicant is requested to point out where support is found in the Specification, wherein the pharmaceutical composition comprises just one component capable of facilitating specific binding to the extracellular domain of SIRPa and blocking the interaction between SIRPa and CD47 and devoid of additional anti-cancer therapeutics. It was not of record in prior filed applications, 17/749,856 (filed 05/20/2022), a CON of 15/518,803 (filed 04/13/2017) is a 371 of PCT/IB2015/058124 (filed 10/21/2015) and foreign application, EPO EP14190370.8 (filed October 24, 2014). Hence, all the claims are afforded the priority date of the instant application, which is April 25, 2024.
Withdrawn Objections
Claim Objections
6. Claim 11 is no longer objected to because the word “myloid” has been deleted, see Amendments to the Claims submitted December 4, 2025.
Withdrawn Grounds of Rejections
Claim Rejections - 35 USC § 112
7. The NEW MATTER REJECTION of claims 11 and 12 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 as set forth in the Final Action mailed August 21, 2025 is withdrawn in light of the deletion of the clause, “wherein the method does not comprise co-administering a tumor-specific antibody”. Claims 13-15 have been cancelled.
Claim Rejections - 35 USC § 102
8. The rejection of claim(s) 11 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Jaiswal et al., US 2011/0014119 A1 (published January 20, 2011/ IDS reference #4 on sheet 1 submitted September 9, 2024) is withdrawn in light of Applicant’s arguments set forth December 4, 2025, on page 10. Claims 13 and 14 have been cancelled.
9. The rejection of claim(s) 11 and 12 is/ under 35 U.S.C. 102(a)(1) as being anticipated by Eckelman et al., WO 2014/123580 A1 (effective filing date 6 August 2013/ IDS reference #10 on sheet 3 submitted September 9, 2024) is withdrawn in light of Applicant’s arguments set forth December 4, 2025, paragraph bridging pages 10 and 11. Claims 13 and 14 have been cancelled.
Claim Interpretation
10. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
11. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation (BRI) of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
Applicant asserts “…the specification identifies the structure corresponding to the means as anti-SIRPa monoclonal antibodies and antigen-binding fragments that bind the extracellular domain of SIRPa and block SIRPa-CD47, and links them to the recited function in vitro and in vivo. i.e., antibodies SE7C2, SE5A5, ED9, and P84” and points are pages 13-17 in the Specification, see Remarks submitted December 4, 2025, page 5, Claim Interpretation segment.
The antibodies recited herein are not cited within the claims and for the reasons of record cited previously and herein, claims 11 and 16 continue to and do invoke 35 U.S.C. 112(f).
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
As currently amended claim 11 recites “…an effective amount of a pharmaceutical composition comprising an anti-signal regulatory protein alpha (SIRPa) antibody or an antigen-binding fragment thereof as the sole active ingredient of the pharmaceutical composition and a pharmaceutical acceptable carrier, the antibody or antigen-binding fragment thereof comprising means for: (i) specifically binding to the extracellular domain of signal regulatory protein alpha (SIRPa) and blocking the interaction between SIRPa and CD47, see lines 3-7 of the claim, see Amendments to the Claims submitted December 4, 2025. This language continues to invoke 135 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The specification does not cite the means, but rather cites a compound or antibody to be implemented in the claimed invention absent of structure that performs the binding functions of binding and blocking.
New claim 16 also invokes 112(f) as it recites “…means for specifically binding…” on line 3 of the claim, wherein there is no structure recited that performs the binding and blocking.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 11, 12, 16 and 17 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. THIS A NEW MATTER REJECTION. 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.
Applicant has amended claim 11 and new claim 16 include limitations, “…method for treating hepatocellular carcinoma or a melanoma,… comprising administering… an effective amount of a pharmaceutical composition comprising an anti-signal regulatory protein alpha (SIRPa) antibody or an antigen-binding fragment thereof as the sole active ingredient of the pharmaceutical composition…”, and “…method for treating hepatocellular carcinoma or a melanoma,… comprising administering… an effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable carrier and means for specifically binding to the extracellular domain of signal regulatory protein alpha (SIRPa), as the sole active ingredient of the pharmaceutical composition…thereby blocking the interaction between SIRPa and CD47,”, respectively. While Applicant states support for these claim amendments reading on these limitations including, “sole active ingredient” “…can at least be found in the Specification as filed on page 19, lines 15 to 21, e.g.”, the Examiner does not concur, see Remarks submitted December 4, 2025, page 3, Support…segment.
The Examiner has reviewed the noted selections of the Specification, as well as the entire Specification and does not see support for sole active ingredient and does not agree that this phrase is synonymous with monotherapy as inferred by Applicant, see Remarks, page 3, Support…segment. As defined by the National Cancer Institute (NCI), monotherapy is “[t]herapy that uses one type of treatment, such as radiation therapy or surgery alone, to treat a certain disease or condition. In drug therapy, monotherapy refers to the use of a single drug to treat a disease or condition.” The NCI also defines an active pharmaceutical ingredient as “[t]he main ingredient in a medicine that causes the desired effect of the medicine. Some medicines contain more than one active pharmaceutical ingredient that act in different ways in the body.” They are different from one another. In the instant case, the claim 11 and claim 16 read on one main ingredient, the SIRPa antibody or an antigen-binding fragment thereof.
Applicant is requested to delete the new matter or specifically state by page, paragraph, or any other identifier where support can be found for the new limitation cited in newly amended claim 11 and new claim 16.
14. The rejection of claims 11, 12 and new claims 16 and 17 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 maintained and made. Claims 13-15 have been cancelled.
Applicant argues “[t]he Office's reasoning appears to be inconsistent with means-plus-function claiming. Per the wording of the statute, claims are not allowed to recite structure corresponding to the means. Further, none of the precedent that the examiner relies upon addresses 35 USC § 112(f) means-plus-function claiming. Applicant believes that it is important for the Office to recognize that the analysis for written description under § 112(a) alone is different, and thus the type of support needed not the same, from the standard when the claim invokes § 112(f).”, see Remarks submitted December 4, 2025, page 7.
Applicant continues these argues noting Abbvie V. Centocor (Fed. Cir. 2014), the Court decision and how those claims were not means-plus-function claims, see page 7 of Remarks.
Applicant recites its former response submitted June 2, 2025, wherein [t]he Office (Appeals Review Panel of the Patent Trial and Appeal Board (ARP); Appeal 2022-001944) has only recently clarified that means-plus-function limitations comprising a means for binding were not only definite under 35 USC § 112 ¶ 2, but that with the disclosure of an antibody, the means were adequately described under 35 U.S.C. § 112(a).”, see bridging paragraph (para.) of pages 7 and 8 in the instant Remarks.
“The ARP held: “Accordingly, we hold that it is not necessary for the Specification here to describe equivalents of 5G 1.1 to meet the definiteness or written description requirements…Specifically, the ARP determined that the disclosure of monoclonal antibody in the Specification provided adequate structure corresponding to the “means for binding,” thereby satisfying the written description requirement and that a person of ordinary skill in the art would understand the “means for binding” limitation as definite.”, see page 8, 1st para.
Applicant relies on the ARP decision, as well as US patents that recited means-plus-function antibody claims, see page 8 of the Remarks.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
Applicant is reminded each case is independent, examined and decided upon on its own individual limitations and merits. Moreover, the cited Patent Trial and Appeal Board decision is not precedential and the Examiner will continue to follow the statutes and rules set forth in the Manual of Patent Examining Procedure. Accordingly, the rejection is maintained based on the analysis set forth herein.
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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims continue to read on methods of treating hepatocellular carcinoma or a melanoma administering a means for specifically binding an anti-signal regulatory protein alpha (anti- SIRPa) monoclonal antibody or an antigen-binding fragment thereof or means for blocking the SIRPa pathway, as well as a second therapeutic agent.
The written description in this instant case seems to set forth three SIRPa antibody species, P84 clone (see page 13, line 30; page 14, line 11; and page 17, lines 5 and 17), clone SE7C2 (see page 14, line 33; and page 15, line 11), clone ED9 (see page 15, line 27) and not a plethora of molecules the broad genus of molecules within the breadth of “means” that the claims set forth, see page 13, Figure 15 caption; page 15, 1st full paragraph; and 2nd line from the bottom.
The instant application does not provide sufficient guidance as to the nexus or correlation between the structure and function of the undefined means for specifically binding SIRPa that places the skilled artisan in possession of the relevant identifying characteristics of a genus of antibodies thereof commensurate in scope with the claimed invention.
In Abbvie v. Centocor (Fed. Cir. 2014), the Court held that a disclosure of many different antibodies (in that case neutralizing antibodies to IL-12 with a particular binding affinity) was not enough to support the genus of all IL-12 neutralizing antibodies because the disclosed antibodies were very closely related to each other in structure and were not representative of the full diversity of the genus. The Court further noted that functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support especially in technology fields that are highly unpredictable where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
“A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
Vas-Cath Inc. V Mahurkar, 19 U5PQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 115).
The skilled artisan cannot envision the detailed structure of the molecules encompassed by the breadth of means for specifically binding to the extracellular domain of SIRPa, thereby blocking the SIRPa pathway therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it. The polypeptide itself is required. See Fiers v. Revel, 25 U5PQ 2d 1601 at 1606 (CAFC1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Lts. 18 U5PQ2d 1016.
Furthermore, In The Reagents of the University of California v. Eli Lilly (43 U5PQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of DNA molecules, usually defined by a nucleotide sequence, falling within the scope of the claimed genus. At section B(l), the court states that "An adequate written description of a DNA...'requires a precise definition, such as by structure, formula, chemical name, or physical properties', not a mere wish or plan for obtaining the claimed chemical invention".
At the time the application was filed Applicants seem to not be in possession of all means for specifically binding SIRPa. The specification does not evidence the possession of all binding molecules that are undefined and uncharacterized falling within the potentially large genus to establish possession. No corollary nexus has been established between structure and function.
The USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018. See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
The Memo clarifies the applicability of USPTO guidance regarding the written description requirement of 35 U.S.C. § 112(a) concerning the written description requirement for claims drawn to antibodies, including the following.
“In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional”.
There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of molecules regarded as means able to specifically bind to the SIRPa and block the SIRPa pathway essential to the claimed invention to demonstrate possession that fulfill the requirements of a structure-function relationships of written description. Also, see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
“When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” See Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted.
To show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
The instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the genus and/or structural common to the members of the genus so the one of skill in the art can visualize or recognize the members of the genus of “means” that specifically bind to SIRPa. Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemical name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
Here, Applicants’ claims include undefined and uncharacterized means for specifically binding to the extracellular domain of SIRPa and functional attributes to fulfill the requirements of a structure-function relationships of written description, but does not describe the structure-identifying information about the antibodies, nor describe a representative number of species falling with the scope of the genus or structural common to the members of the genus so the one of skill in the art can visualize or recognize the member of the genus of the actual said antibodies.
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that exhibit this functional property.
The specification does not evidence the possession of all binding molecules falling under the purview of “means”, which are undefined and uncharacterized falling within the potentially large genus to establish possession. Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 U5PQ2d 1398.
The full breadth of the claims do not meet the written description provision of 35 U.S.C. 112, first paragraph.
15. 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.
16. The rejection of claims 11, 12 and new claims 16 and 17 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 is maintained and made. Claims 13-15 have been cancelled.
The Remarks submitted December 4, 2025 do not address the instant rejection, 35 U.S.C. 112(b), hence the rejection is maintained and made.
a. The claims continue to not have clear structural definition for “...means for blocking the Signal Regulatory Protein Alpha (SIRPa) pathway...”.
Applicant has asserted previously “we hold that it is not necessary for the Specification here to describe equivalents of 5G 1.1 to meet the definiteness or written description requirements.”
[“]Specifically, the ARP determined that the disclosure of monoclonal antibody in the Specification provided adequate structure corresponding to the “means for binding,” thereby satisfying the written description requirement and that a person of ordinary skill in the art would understand the “means for binding” limitation as definite.
The presently presented means-plus-function claim 11 and disclosure of the present Specification comport to the ARP’s decision and thus the rejection should respectfully be withdrawn.”, see former Remarks submitted June 2, 2025, page 7, paras. 2-4.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
Applicant is reminded each case is independent, examined and decided upon on its own individual limitations and merits. Moreover, the cited Patent Trial and Appeal Board decision is not precedential and the Examiner will continue to follow the statutes and rules set forth in the Manual of Patent Examining Procedure. Accordingly, the rejection is maintained based on the analysis set forth herein.
For the purpose of expedited prosecution, the recitation, “means for” is interpreted to be an antibody or structural variance thereof that is capable of performing the corresponding function. However, the metes and bounds cannot be determined given the indefiniteness of the recitation and lack of knowledge and description of equivalents.
Claim Rejections - 35 USC § 102
17. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
18. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
19. The rejection of claim(s) 11, 12 and new claims 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pons et al., WO 2018/057669 (published 29 March 2018) is maintained and made. Claims 13-15 have been cancelled.
Applicant asserts Pons is not prior art in view of the priority date, see Remarks submitted December 4, 2025, page 9, 35 USC § 102 segment, a. However, given the new matter cited in independent claims 11 and 16, the afforded priority date is that of the filing of the instant application, April 25, 2024. Accordingly, the rejection is maintained and made.
Pons antibodies are the sole active ingredient able to facilitate the desired effect, specifically binding to the extracellular domain of SIRPa and blocking the interaction betwen SIRPa and CD47.
Pons discloses methods of treating melanoma and hepatocellular carcinoma and associated metastases with antibodies that bind an extracellular domain of a human SIRP-a v1 polypeptide and SIRP-a v2 polypeptide or both, see abstract; paragraph (para.) bridging pages 2 and 3; page 67, section 0147; and Methods of Treatment segment, sections 0308, 0309, 312 and 313 spanning pages 167-170.
The disclosed antibodies are administered in combination with a cytotoxic agent including chemotherapeutic agents, radioactive isotopes, antibiotic agents and an immunotherapeutic agents, see page 65, section 0140; and Methods of Treatment spanning pages 167-170.
“In some embodiments, an antibody of the present disclosure is administered in combination with an immunotherapeutic agent. An immunotherapeutic agent may refer to any therapeutic that targets the immune system and promotes a therapeutic redirection of the immune system, such as a modulator of a costimulatory pathway, cancer vaccine, recombinantly modified immune cell, etc. In some embodiments, the immunotherapeutic agent comprises an antibody. Exemplary antigens of immunotherapeutic antibodies are known in the art and include without limitation PD-1, PD-L1, OX40, CTLA-4, CD137/4- 1BB, B7-H3, FZD7, CD27, TNFR2, CCR4, CSF1R, CSF, TIM-3, LAG-3, VISTA, ICOS, CCR2, IDO, A2R, CD39, CD73, TIGIT, CD80, CD47, arginase, TDO, and PVRIG. Immunotherapeutic agents that are approved or in late-stage clinical testing include, without limitation, ipilimumab, pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab, and the like. Without wishing to be bound to theory, it is thought that the antibodies of the present disclosure are suitable for use with immunotherapeutic agents due to complementary mechanisms of action, e.g., in activating both macrophages and Teffector cells to target tumor cells. In certain embodiments, an antibody of the present disclosure is administered in combination with an inhibitor of the PD-L1/PD-1 pathway, e.g., an anti-PD-L1 or anti-PD-1 antibody. As demonstrated herein, combined administration of an anti-SIRP-α antibody of the present disclosure and an inhibitor of the PD-L1/PD-1 pathway can result in synergistic anti-tumor activity.”, see page 169, section 0312.
With the administration of the disclosed antibodies the means are provided for specifically binding to the extracellular domain of SIRPa and blocking the SIRPa pathway.
As noted in the pending 35 U.S.C. 112(b), for the purpose of expedited prosecution, the recitation, “means” for is interpreted to be an antibody or structural variance thereof that is capable of performing the corresponding function. Accordingly, the rejection reads on independent claims 11, 16 and their dependent claims.
20. The rejection of claim(s) 11 and new claim 16 under 35 U.S.C. 102(a)(1) as being anticipated by Von Andrian et al., US 2010/0233251 A1 (published September 16, 2010/ IDS reference #2 on sheet 1 submitted September 9, 2024) is maintained and made. Claims 13-15 have been cancelled.
Applicant argues “[c]laim 11 relates to a method using a pharmaceutical composition, wherein an anti-signal regulatory protein alpha (SIRPa) antibody or an antigen-binding fragment thereof is used as the sole active ingredient in the pharmaceutical composition. Von Adrian et al. relates to vaccine nanocarriers that comprise multiple components. Von Adrian et al. refers to a DC targeting moiety specifically binding to DC markers, including SIRP-1a (amongst numerous listed targets), wherein this targeting moiety is used in combination with additional immunomodulatory agents in the vaccine nanocarrier, see e.g. paragraphs 78-87.
Because Von Andrian et al. does not teach the element "as the sole active ingredient," claim 11 is novel over Von Andrian et al.”, see Remarks submitted December 4, 2025, see Remarks submitted December 4, 2025, 35 USC § 102 segment, b. spanning pages 9 and 10.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
Von Andrian antibodies are the sole active ingredient able to facilitate the desired effect, specifically binding to the extracellular domain of SIRPa and blocking the interaction between SIRPa and CD47, while the additional agents do not. Hence, the rejection is maintained and made.
Von Andrian discloses methods of treating melanoma and liver (hepatocellular) cancer with a combination of therapeutic agents including a targeting moiety including T cell targeting moieties, see page 37, 1st column, line 24; and page 49, sections 0460, 0465 and 0466. The targeting moiety specifically binds SIRP-1a, see page 26, section 0242 and in particular page 27, 1st column, line 24. The T cell targeting moieties bind immune checkpoint proteins including CD86 (B7-2/B70), CD152 (CTLA-4), CD274 (B7H1, PDL1), CD279 (PD1) and a host of others in sections 0243-0246 spanning pages 26-28. The anti-SIRP-1 antibody can be administered in combination with binding moieties that bind said immune checkpoint proteins, thereby inducing and modulating an immune response, see page 49, section 0460.
With the administration of the disclosed antibodies the means are provided for specifically binding to the extracellular domain of SIRPa and blocking the SIRPa pathway.
As noted in the pending 35 U.S.C. 112(b), for the purpose of expedited prosecution, the recitation, “means” for is interpreted to be an antibody or structural variance thereof that is capable of performing the corresponding function. Accordingly, the rejection reads on claim 11, claim 16 and its dependent claims.
Claim Rejections - 35 USC § 103
21. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
22. 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, 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.
23. The rejection of claims 11, 12 and new claims 16 and 17 under 35 U.S.C. 103 as being unpatentable over Von Andrian et al., US 2010/0233251 A1 (published September 16, 2010/ IDS reference #2 on sheet 1 submitted September 9, 2024), and further in view of Singh et al., US 2012/0070461 A1 (March 22, 2012/ IDS reference #5 on sheet 1 submitted June 15, 2023) is maintained and made. Claims 13-15 have been cancelled.
Applicant argues primary reference, “Von Andrian…expressly discloses administration of an anti-SIRPa antibody together with additional active agents,” and secondary reference, “Singh…does not contain any teaching or suggestion of using an anti-SIRPa antibody as the sole active ingredient in a therapeutic use.”, see page 11 of the Remarks submitted December 4, 2025.
Applicant’s arguments have been carefully considered, but found unpersuasive.
As set forth in the pending 102 rejection, the taught Von Andrian antibodies are the sole active ingredient able to facilitate the desired effect, specifically binding to the extracellular domain of SIRPa and blocking the interaction between SIRPa and CD47. Hence, the rejection is maintained and made.
Von Andrian teaches methods of treating melanoma and liver (hepatocellular) cancer and melanoma with a combination of therapeutic agents including a targeting moiety including T cell targeting moieties, see page 37, 1st column, line 24; and page 49, sections 0460, 0465 and 0466. The targeting moiety specifically binds SIRP-1a, see page 26, section 0242 and in particular page 27, 1st column, line 24.
Von Andrian does not teach the taught method, wherein the hepatocellular carcinoma or melanoma are metastatic.
However, Singh teaches metastatic disorders including hepatocellular (liver) carcinoma and melanomas can be treated, see page 1, section 0012; and page 5, section 0050. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat a particular subset of proliferative disorders, see both references. One of ordinary skill in the art would have been motivated to treat metastatic forms of these cancer given it is known in the art as set forth in the references, see both references in their entireties.
With the administration of the disclosed antibodies the means are provided for specifically binding to the extracellular domain of SIRPa and blocking the SIRPa pathway.
As noted in the pending 35 U.S.C. 112(b), for the purpose of expedited prosecution, the recitation, “means” for is interpreted to be an antibody or structural variance thereof that is capable of performing the corresponding function. Accordingly, the rejection reads on claim 11, claim 16 and its dependent claims.
24. The rejection of claim(s) 11, 12 and new claims 16 and 17 under 35 U.S.C. 103 as being unpatentable over Von Andrian et al., US 2010/0233251 A1 (published September 16, 2010/ IDS reference #2 submitted June 15, 2023), and further in view of Jaiswal et al., US 2011/0014119 A1 (published January 20, 2011/ IDS reference #4 on sheet 1 submitted September 2024) is maintained and made. Claims 13-15 have been cancelled.
Applicant argues primary reference, “Von Andrian…expressly discloses administration of an anti-SIRPa antibody together with additional active agents,” and “[n]othing in Von Andrian…contemplates, suggests, or provides motivation for using the anti-SIRPa antibody as the sole active ingredient.”, see page 11 of the Remarks submitted December 4, 2025.
Applicant further states Jaiswal does not utilize the said antibodies as administered therapeutic agents and “…not as sole therapeutics.”, see last paragraph on page 11.
Applicant’s arguments have been carefully considered, but found unpersuasive.
As set forth in the pending 102 rejection, the taught Von Andrian antibodies are the sole active ingredient able to facilitate the desired effect, specifically binding to the extracellular domain of SIRPa and blocking the interaction between SIRPa and CD47. Hence, the rejection is maintained and made.
Von Andrian teaches pharmaceutical compositions including targeting moieties or targeting agents, antibodies that specifically target SIRP-1a, see abstract; page 10, section 0087; page 26, sections 0242 and 0243; and page 28, section 0246; sections 0265-0267 bridging pages 29 and 30; page 35, section 0324; and Pharmaceutical…section beginning on page 50. Several types of solid cancers including liver (hepatocellular) carcinoma and melanoma may be treated with the said administration, see page 49, section 0466.
Von Andrian does not teach methods of treating metastatic liver (hepatocellular) carcinoma and metastatic melanoma with anti-SIRP monoclonal antibody, thereby disrupting the interaction between SIRPa and CD47.
However, Jaiswal teaches treating cancer disorders including metastatic cells, as well as melanomas and “solid tumors [that have metastasized] to macrophage rich tissues such as liver” with therapeutic antibodies, see page 8, section 0075; page 11, sections 0096, 0097 and 0102; page 13, section 0122; page 28, section 0253; and last sentence in section 0263 on page 29.
With the administration of the taught antibodies the means are provided for specifically binding to the extracellular domain of SIRPa and blocking the SIRPa pathway.
It would have been obvious to one of ordinary skill in the art at the effective filing date of the claimed invention was made to treat not only liver cancer and melanoma, but those that were metastatic as taught in Jaiswal.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in both references to implement the combination of anti-neoplastic agents for the treatment of metastatic malignancies because both documents teach successful implementation of antibodies able to disrupt CD47-SIRPa interaction, see Von Andrian abstract; page 10, section 0087; page 26, sections 0242 and 0243; page 28, section 0246; sections 0265-0267 bridging pages 29 and 30; page 35, section 0324; and Pharmaceutical…section beginning on page 50; see page 49, section 0460; and Jaiswal see page 8, section 0074; page 25, section 0223; see page 9, section 0079; page 13, section 0122; page 17, section 0155; and section 0263 on page 29.
As noted in the pending 35 U.S.C. 112(b), for the purpose of expedited prosecution, the recitation, “means” for is interpreted to be an antibody or structural variance thereof that is capable of performing the corresponding function. Accordingly, the rejection reads on claim 11 and its dependent claims.
Conclusion
25. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
17 December 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643