Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/23/2026 has been entered.
Priority
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. Claims 20 and 32-35 have an effective filing date of 06FEB2020.
Election/Restriction
In the response filed on 7/18/2025, Applicant elected:
Species
CXCL12 Inhibitor – Anti-CXCL12 antibody
CSF1 Inhibitor – Anti-CSF1 antibody
Cancer immunotherapy agent – Anti-PD-1 antibody
Status of Claims
Claims 20 and 32-35 are currently pending and presented for examination on the merits.
Claims 20 and 35 are amended.
Claims 1-19, and 21-31 are canceled.
Rejections Withdrawn
The rejections filed under 35 U.S.C. 103 are withdrawn in view of Applicant’s amendments to claims.
New Grounds of Rejection
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 the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20, and 32-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the claims are inclusive of a genus of a CXCL12 inhibitory antibody. However, the written description in this case only sets forth anti-CXCL12 antibody K15C. The specification does not disclose, and the art does not teach, the genus of CXCL12 inhibitory antibodies as broadly encompassed in the claims.
The specification discloses a CXCL12 inhibitory antibody. However, the written description only reasonably conveys anti-CXCL12 antibody K15C. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of anti-CXCL12 antibodies that encompass the genus of anti-CXCL12 antibodies nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the 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.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Further, in view of Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) and the Office’s February 2018 memo clarifying written description guidance for claims drawn to antibodies, the 2008 Written Description Training Materials are outdated and should not be relied upon as reflecting the current state of law regarding 35 U.S.C. 112. Further, a “newly characterized antigen” test flouts basic legal principles of the written description requirement (Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017)). Adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen. Where an antibody binds to an antigen tells one nothing about the structure of any other antibody. Also, see the Board’s recent decision in Appeal 2017-010877 (claims to “A monoclonal antibody that binds a conformational epitope formed by amino acids 42-66 of SEQ ID NO:1”).
The functional requirements of the claimed antibodies is the sort of wish list of properties which fails to satisfy the written description requirement because “antibodies with those properties have not been adequately described.” Centocor, 636 F.3d at 1352.
The “claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad Pharmaceuticals, Inc. v. EliLilly and Co.,598 F.3d 1336, 1353 (Fed. Cir. 2010).
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of anti-CXCL12 antibody K15C is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and 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 reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. 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 1115).
Absent empirical data that demonstrates the CXCL12 antibody possess the inhibitory CXCL12 effect necessary to treat colorectal cancer, one of ordinary skill in the art would not recognize features an anti-CXCL12 antibody needs to inhibit CXCL12 sufficiently to treat colorectal cancer in a subject.
Claims 20, and 32-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the claims are inclusive of a genus of a CSF1 inhibitory antibody. However, the written description in this case only sets forth anti- CSF1 antibody 5A1. The specification does not disclose, and the art does not teach, the genus of CSF1inhibitory antibodies as broadly encompassed in the claims.
The specification discloses a CSF1 inhibitory antibody. However, the written description only reasonably conveys anti-CSF1 antibody 5A1. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of anti- CSF1antibodies that encompass the genus of anti-CSF1 antibodies nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the 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.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Further, in view of Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) and the Office’s February 2018 memo clarifying written description guidance for claims drawn to antibodies, the 2008 Written Description Training Materials are outdated and should not be relied upon as reflecting the current state of law regarding 35 U.S.C. 112. Further, a “newly characterized antigen” test flouts basic legal principles of the written description requirement (Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017)). Adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen. Where an antibody binds to an antigen tells one nothing about the structure of any other antibody. Also, see the Board’s recent decision in Appeal 2017-010877 (claims to “A monoclonal antibody that binds a conformational epitope formed by amino acids 42-66 of SEQ ID NO:1”).
The functional requirements of the claimed antibodies is the sort of wish list of properties which fails to satisfy the written description requirement because “antibodies with those properties have not been adequately described.” Centocor, 636 F.3d at 1352.
The “claims merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim’s functional boundaries— leaving it to the pharmaceutical industry to complete an unfinished invention.” Ariad Pharmaceuticals, Inc. v. EliLilly and Co.,598 F.3d 1336, 1353 (Fed. Cir. 2010).
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of anti-CSF1 antibody 5A1 is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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). As discussed above, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and 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 reference to a potential method of isolation. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. 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 1115).
Absent empirical data that demonstrates the CSF1 antibody possess the inhibitory CSF1 effect necessary to treat colorectal cancer, one of ordinary skill in the art would not recognize features an anti-CSF1 antibody needs to inhibit CSF1 sufficiently to treat colorectal cancer in a subject.
Claim Rejections Maintained - 35 USC § 103
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.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 20, 32-33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al (WO 2019183216 A1), Zboralski et al (Increasing Tumor-Infiltrating T Cells through Inhibition of CXCL12 with NOX-A12 Synergizes with PD-1 Blockade, Cancer Immunol Res; 5(11) November 2017, IDS 8/5/2022), and further in view of Wang et al (Interactions between colon cancer cells and tumor-infiltrated macrophages depending on cancer cell-derived colony stimulating factor 1, ONCOIMMUNOLOGY, 2016, VOL. 5, NO. 4, e1122157 (12 pages), Previous OA).
In regard to claim 20, Goldberg et al teaches a method of treating cancer [Abstract]. Goldberg et al further teaches a drug delivery composition comprising anti-PD-1 antibodies to activate the adaptive immune system [Abstract]. Goldberg et al further teaches the drug delivery compositions comprises an inhibitor of a proinflammatory pathway [0097]. Goldberg et al further teaches the inhibitor of the proinflammatory pathway is a CXCL12 inhibitor [0099]. Goldberg et al further teaches an anti-CXCL12 antibody [0217]. Goldberg et al further teaches the drug delivery compositions comprises a modulator of macrophage effector function [0228]. Goldberg et al further teaches the modulator of macrophage effector function is an anti-CSF1 antibody [0229].
Goldberg et al does not specifically teach using a CXCL12 inhibitor to treat colorectal cancer. However, this deficiency is made up in the teachings of Zboralski et al.
Zboralski et al teaches a method of treating colorectal cancer [Abstract]. Zboralski et al further teaches administering a CXCL12 inhibitor NOX-A12 and anti-PD-1 therapy [Abstract].
Goldberg et al does not specifically teach using a CSF1 inhibitor to treat colorectal cancer. However, this deficiency is made up in the teachings of Wang et al.
Wang et al teaches CSF1 is over-expressed in colon cancer [Abstract]. Wang et al further teaches an inhibitor of CSF1, CSF1-neutralizing antibody CSF1 Nab [Right column, 3rd Paragraph, pg. 4].
One of ordinary skill, before the effective filing date would have been motivated to combine Goldberg’s methods for a method of treating colorectal cancer comprising a CXCL12 inhibitory antibody, an CSF1 inhibitory antibody, and an anti-PD-1 antibody, with Zboralski’s method of treating colorectal cancer comprising an anti-CXCL12 antibody and PD-1 antibody, with Wang’s method of treating colorectal cancer comprising an anti-CSF1 antibody. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143.It would have been prima facie obvious to combine Goldberg, Zboralski, and Wang’s methods for a method of treating colorectal cancer comprising administering an anti-CXCL12 antibody, an anti-CSF1 antibody, and an anti-PD-1 antibody, because Goldberg teaches a drug delivery composition for the treatment of cancer, including colorectal, comprising an inhibitor of PD-1 to activate the adaptive immune system, an inhibitor of CXCL12 to inhibit the proinflammatory pathway, and an inhibitor of CSF1 to modulate the function of macrophages. Furthermore, Zboralski teaches treating colorectal cancer comprising CXCL12 and PD-1 inhibitory antibodies, and Wang teaches treating colorectal cancer comprising an anti-CSF1 antibody.
In regard to claim 32, Zboralski et al further teaches inhibition of CXCL12 helps to overcome the resistance to anti-PD-1 treatment [2nd Paragraph, pg. 955].
In regard to claim 33, Zboralski et al further teaches the expression level of CXCL12 of a cancer [Left column, 2nd Paragraph, pg. 950]. Zboralski et al further teaches the expression levels of CXCL12 [Figure 1]. Zboralski et al further teaches CXCL12 expression confers resistance to checkpoint inhibitors [Left column, 2nd Paragraph, pg. 950]. Wang et al further teaches the expression level of colon cancer cells [Fig. 5]. Wang et al further teaches CSF1 is overexpressed in colon cancer cells [Abstract].
In regard to claim 35, Zboralski et al further teaches the expression level of CXCL12 of a cancer [Left column, 2nd Paragraph, pg. 950]. Zboralski et al further teaches the expression levels of CXCL12 [Figure 1]. Zboralski et al further teaches CXCL12 expression confers resistance to checkpoint inhibitors [Left column, 2nd Paragraph, pg. 950]. Zboralski et al further teaches administering a CXCL12 inhibitor NOX-A12 and anti-PD-1 therapy [Abstract].
Claims 20, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al (WO 2019183216 A1), Zboralski et al (Increasing Tumor-Infiltrating T Cells through Inhibition of CXCL12 with NOX-A12 Synergizes with PD-1 Blockade, Cancer Immunol Res; 5(11) November 2017, IDS 8/5/2022), Wang et al (Interactions between colon cancer cells and tumor-infiltrated macrophages depending on cancer cell-derived colony stimulating factor 1, ONCOIMMUNOLOGY, 2016, VOL. 5, NO. 4, e1122157 (12 pages), Previous OA) as applied to claims 20, 32-33, and 35 above, and further in view of Al-Grawi et al (Expression of CDKN2A (p16/Ink4a) among Colorectal Cancer Patients: A cohort study, J. Pharm. Sci. & Res. Vol. 10(5), 2018, 1145-1147, Previous OA).
The teachings of Goldberg et al, Zboralski et al, and Wang et al are discussed above.
Goldberg et al does not specifically teach the expression of p16INK4A. However, this deficiency is made up in the teachings of Al-Grawi et al.
In regard to claim 34, Al-Grawi et al teaches 75% of colorectal cancer cells expressed p16INK4A [Abstract].
One of ordinary skill, before the effective filing date, would have been motivated to combine Goldberg’s methods for a method of treating colorectal cancer comprising a CXCL12 inhibitory antibody, an CSF1 inhibitory antibody, and an anti-PD-1 antibody, with Zboralski’s method of treating cancer comprising administering a CXCL12 inhibitor and anti-PD-1 therapy, with Wang’s method of treating cancer comprising administering a CSF1, with Al-Grawi’s method of showing 73% of colon cancer cells express p16INK4A. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Goldberg, Zboralski, Wang, and Al-Grawi’s methods for a method of treating colorectal cancer to a subject in need there of comprising administering a CXCL12 inhibiting antibody, a CSF1 inhibitor, and a cancer immunotherapy agent, Goldberg teaches a drug delivery composition for the treatment of cancer, including colorectal, comprising an inhibitor of PD-1 to activate the adaptive immune system, an inhibitor of CXCL12 to inhibit the proinflammatory pathway, and an inhibitor of CSF1 to modulate the function of macrophages. Furthermore, Al-Grawi et al teaches p16INK4A over expression in 73% of colon cancer cells compared to negligible expression in control samples and many of the colorectal cancer patients treated with the intervention of Zboralski et al and Wang et al will necessarily have increased expression of p16INK4A.
In Applicant Arguments, dated 05/26/2026, Applicant points out that “[o]n pages 3-4 of the Final Office Action, the Examiner acknowledges that Applicant's evidence ‘demonstrates an unexpected efficacy attributable to the simultaneous inhibition of CXCL12, PD-1, and CSF1,’ and indicated that allowance could be obtained if the claims were commensurate in scope with the data, namely, treatment with a CXCL12 inhibitory antibody, a CSF1 inhibitory antibody, and a PD-1 inhibitory antibody. As amended, the claims are now commensurate in scope with the supporting data of record. As described in the published application at paragraphs [0166]-[0168], co-administration of the anti-CXCL12 antibody (clone K15C), the anti-CSF1 antibody (clone 5A1), and the anti-PD-1 antibody resulted in an average tumor size reduction of 76.1%, approximately 2 to 3 times greater than the reduction observed with any single antibody and approximately 1.5 times greater than the reduction observed with co-administration of the anti-CXCL12 and anti-PD-1 antibodies. See also paragraph [0055].”
These arguments are not sufficient to overcome the rejection of the claims under 35 U.S.C. 103, because independent claims 20 and 35 are not commensurate in scope with Applicant’s evidence of unexpected results. As indicated by applicant “the co-administration of the anti-CXCL12 antibody (clone K15C), the anti-CSF1 antibody (clone 5A1), and the anti-PD-1 antibody resulted in an average tumor size reduction of 76.1%, approximately 2 to 3 times greater than the reduction observed with any single antibody and approximately 1.5 times greater than the reduction observed with co-administration of the anti-CXCL12 and anti-PD-1 antibodies.” Given that the independent claims are broadly drawn to any anti-CXCL12 antibody and any anti-CSF1 antibody said claims are not commensurate in scope with Applicant’s evidence of unexpected results, and as such the rejection of the claims under 35 U.S.C. 103 are maintained.
Conclusion
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
