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 .
2. Claims 11, 12 and 16-19 are pending.
Claims 11 and 16 have been amended.
Claims 18 and 19 have been added.
Claims 11, 12 and 16-19 are examined on the merits.
3. 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
4. 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 complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112, 1st as the claims have deleted the limitation, “…sole active ingredient of the pharmaceutical composition…” from claims 11 and 16, see Amendments to the Claims submitted May 26, 2026. Hence, all the claims are afforded the priority date of the foreign application, EPO EP14190370.8 (filed October 24, 2014).
Claim Interpretation
5. 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.
6. 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 no longer invoked for claim 11 because the claim cites an agent with structure that is administered is an antibody or an antigen-binding fragment thereof is a structural modifier, defined in the specification as a particular structure or known by one skilled in the art, that denotes the type of structural device (e.g., ‘filters’)” (MPEP 2181 § I.C). The “means for binding” is preceded by the statement that it is a component of an antibody. An antibody is a structural device that performs the function of binding epitopes. So “means for binding” here is disqualified from 112(f), see MPEP § 2181, subsection I.
However, 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 asserted “…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, claim 16 continues to and does 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 16 recites “…a pharmaceutical composition comprising a pharmaceutically acceptable carrier and means for specifically binding…and blocking…” on lines 3-6 of the claim, wherein there is no structure recited that performs the binding and blocking. 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.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
7. The NEW MATTER REJECTION of claims 11, 12, 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 withdrawn in light of the amendment to claims 11 and 16 deleting “as the sole active ingredient of the pharmaceutical composition”, see Amendments to the Claims submitted May 26, 2026.
8. The rejection of claims 11 and 12 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 withdrawn as the claims read on an antibody or antigen-binding fragment thereof makes clear there is structure giving light to the “...means for…” the binding and blocking the interaction between SIRPa and CD47, see Amendments to the Claims submitted May 26, 2026.
Claim Rejections - 35 USC § 102
9. The rejection of claim(s) 11, 12, 16 and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Pons et al., WO 2018/057669 (published 29 March 2018) is withdrawn in light of the newly afforded priority date is that of the filing of the foreign application, EPO EP14190370.8 (filed October 24, 2014).
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
10. 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.
11. The rejection of claims 11, 12, 16, 17 and new claims 18 and 19 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.
Applicant asserts their beliefs, “…the Examiner chooses not [to] apply the written description stand for means-plus-function claims to Applicant’s means-plus-function claims, but instead chooses to apply a different written description standard”, “…that under Federal Circuit jurisprudence, Applicant's claims to methods of using a well-known type of antibody to treat a specific medical condition [satisfies] the written description requirement”, see Remarks submitted May 26, 2026, paragraph (para.) bridging pages 6 and 7; and page 7, 1st full para.
“Applicant respectfully brings to the Office's attention the recent Federal Circuit decision in Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, No. 2024- 1094 (Fed. Cir. Apr. 16, 2026)”, wherein Applicant is of the point of view the “when the antibody genus is well known in the art and is not itself the invention - the invention being a new therapeutic use - the written description and enablement requirements are assessed against that background knowledge and are distinguishable from the requirements for a claim to a novel antibody genus per se.”, see Remarks, last para. on page 7.
Applicant continues arguments alleging Teva’s relevance to the instant claims, as well as asserting Amgen v. Sanofi is not applicable to the claimed invention, see pages 8-10. Applicant state “[a]ll members of the genus work in the claimed method” pointing out evidence within their Specification, see bulleted segment spanning pages 8 and 9. And concluding the instant claims are not drawn to the antibodies themselves, but are method-of-use claims, see page 10, lines 1-9.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
Contrary to Applicant’s assertions the Teva case does differ from the claimed invention, wherein the antibodies of the instant invention require particular antibodies to specifically bind a particular segment or epitope (extracellular domain of SIRPa) in order to facilitate the requisite blocking interaction between SIRPa and CD47. In Teva it was made clear that all anti-CGRP antagonist antibodies could bind multiple regions of CGRP and accomplish the method endpoint.
While Applicant asserts “[a]ll members of the genus work in the claimed method”, the biology of this interaction does not bear out that fact, wherein the Specification states “[t]his comprises administering a drug comprising a substance that specifically recognizes the extracellular domain of SIRPa and inhibits the functioning of pathologic myeloid cells.”, see page 9 of the Remarks, 1st bullet; and Specification page 8, 2nd paragraph. Absent evidence to the contrary, it is art known that the blocking only occurs at the extracellular domain, the only site of direct interaction. Accordingly, the claimed invention and the facts of Teva governing the Teva decision are distinct and cannot be extrapolated from one case to another.
The functional properties of the antibodies implemented in the instant claimed invention required by the claims is analogous to Amgen v. Sanofi, wherein the antibodies were required to bind a specific epitope as required for the claimed invention.
Once again, Applicant is reminded each case is independent, examined and decided upon on its own individual limitations and merits. 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 (and metastatic versions of these cancers) with the administration of an effective amount of a pharmaceutical composition comprising an anti-signal regulatory protein alpha (SIRPa) monoclonal antibody or an antigen-binding fragment thereof or means for blocking the interaction between SIRPa and CD47.
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”, as well as the antibody or antigen-binding fragment thereof, 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.
12. 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.
13. The rejection of 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.
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 “...a pharmaceutical composition comprising a pharmaceutically acceptable carrier and means for specifically binding to the extracellular domain of the signal regulatory protein alpha (SIRPa), …and blocking the interaction SIRPa and CD47, see lines 3-6 of claim 16.
Applicant argues “[a] claim is not indefinite merely because it
uses functional language, provided that the specification discloses corresponding structure linked to the recited function (MPEP § 2181.II.A).”, see Remarks submitted May 26, 2026, page 10, last full paragraph; and pages 11-13.
Applicant points out other publications, patent and examples within their Specification, noting it “provides the ‘corresponding structure’ for the means for limitations for claims 11 and 16.”, see pages 12 and 13.
Applicant’s arguments, Specification and points of view have been carefully considered, but fail to persuade.
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, hence this rejection does not read on claim 11. However, the means-plus-function claim 16 and disclosure of the present Specification do not comport to judicial decisions and thus the rejection is maintained for the reasons of record and herein.
Applicant is reminded each case is independent, examined and decided upon on its own individual limitations and merits. Moreover, the Examiner will continue to follow the statutes and rules set forth in the Manual of Patent Examining Procedure.
Claim Rejections - 35 USC § 102
14. 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.
15. 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.
16. The rejection of claim(s) 11, 16 and new claim 18 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.
Applicant argues the claims as amended and added require monotherapy and “…CD172/SIRP-1a [is] one possible marker among many other markers…”, see Remarks submitted May 26, 2026, 35 USC § 102 segment spanning pages 14 and 15.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
Teachings amongst other embodiments do not preclude those teachings from
reading on the claim limitations. “[W]hen the species is clearly named, the species
claim is anticipated no matter how many other species are additionally named”, see
Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990).
Notwithstanding, Von Andrian antibodies within a vaccine nanocarrier may comprise a single type of targeting moiety that directs delivery, as well as the pharmaceutical composition may be administered alone or as a single composition, see page 10, sections 0082 and 0092; page 11, section 0095; page 24, section 0216; page 31, section 0287; page 34, section 0313; page 37, sections 0337 and 0341; and page 55, sections 0514 and 0516. which reads on monotherapy, absent of additional therapeutic agents 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.
Moreover, 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.” 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.
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 (col.), 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 col., line 24. 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 16 and its dependent claims.
Claim Rejections - 35 USC § 103
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 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.
19. The rejection of claims 11, 12, 16, 17 and new claims 18 and 19 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.
Applicant argues primary reference, “Von Andrian merely lists CD172/SIRP-1a [is] one possible marker among many other markers…”, see Remarks submitted May 26, 2026, paragraph (para.) spanning pages 14 and 15. Applicant also argues the claims as amended and added require monotherapy and, see Remarks submitted May 26, 2026, 35 USC § 103 segment spanning pages 17-19. Concluding that the secondary reference does not cure the alleged deficiencies of the primary reference, see pages 18 and 19.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
As set forth in the pending 102 rejection, Von Andrian is still pending. 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 antibodies within a vaccine nanocarrier may comprise a single type of targeting moiety that directs delivery, as well as the pharmaceutical composition may be administered alone or as a single composition, see page 10, sections 0082 and 0092; page 11, section 0095; page 24, section 0216; page 31, section 0287; page 34, section 0313; page 37, sections 0337 and 0341; and page 55, sections 0514 and 0516. which reads on monotherapy, absent of additional therapeutic agents 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.
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 claim 16 and its dependent claims.
20. The rejection of claim(s) 11, 12, 16, 17 and new claims 18 and 19 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.
Applicant argues primary reference, “Von Andrian merely lists CD172/SIRP-1a [is] one possible marker among many other markers…”, see Remarks submitted May 26, 2026, paragraph (para.) spanning pages 14 and 15. Applicant also argues the claims as amended and added require monotherapy and, see Remarks submitted May 26, 2026, 35 USC § 103 segment spanning pages 19-21. Concluding that the secondary reference does not cure the alleged deficiencies of the primary reference, see pages 20 and 21.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
As set forth in the pending 102 rejection, Von Andrian is still pending. 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 antibodies within a vaccine nanocarrier may comprise a single type of targeting moiety that directs delivery, as well as the pharmaceutical composition may be administered alone or as a single composition, see page 10, sections 0082 and 0092; page 11, section 0095; page 24, section 0216; page 31, section 0287; page 34, section 0313; page 37, sections 0337 and 0341; and page 55, sections 0514 and 0516. which reads on monotherapy, absent of additional therapeutic agents 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.
Von Andrian does not teach the taught 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 16 and its dependent claims.
Conclusion
21. 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.
22. 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
23 July 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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