DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendments and remarks filed 10/14/25 are acknowledged. Claims 1, 7 and 13 have been amended. Claims 4, 10 and 16 are canceled. Claims 1-3, 5-9, 11-15 and 17-18 are pending and under examination.
Withdrawn Rejection
The rejection of claims 1, 3 and 5 under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by Elvin (WO 2013/034660 A1). See pages 17-18 of the previous Office action is withdrawn in light of Applicant’s amendment.
Rejections Maintained
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.
The claims 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.
The claims are directed to methods of administering an antagonistic antibody, or an antigen-binding fragment thereof, (hereinafter referred to as “the antibody product”), wherein the antibody product binds Siglec 15 and decreases the activity of Siglec 15. Dependent claims provide activities of the antibody product (blocks the interaction between Siglec 15 and a binding ligand). The effect of administering the antibody product is recited in the claims as treatment of cancer, reducing tumor size, or increasing an immune response against a tumor. These are all functional limitations; no specific structural limitations are recited for the antibody product. It is noted that an “antibody or antigen-binding fragment thereof” is a class of structure, however it does not provide a detailed structure of the encompassed antibody products such as antibody CDR sequences or reference to a deposited monoclonal antibody. Also, none of the claims provide a structure for the targeted protein Siglec 15. While the specification discusses sources for Siglec 15 structures at p. 17, the specification does not provide a limiting definition of the term “Siglec 15” and thus the claims can be broadly and reasonably interpreted as including Siglec 15 variants as the targeted protein. Accordingly, all of the claims recite a vast genus of antibody products that bind and antagonize a genus of Siglec 15 proteins.
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). An adequate written description of a chemical invention "requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir. 2004); Regents of the Univ. of Cal. v. Eli Lilly & Co., Inc., 119 F.3d 1559, 1566 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). "A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F.3d at 923; Eli Lilly, 119 F.3d at 1568. Instead, the "disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Id. In addition, possession of a genus "may be achieved by means of a recitation of a representative number of [compounds]... falling within the scope of the genus." Eli Lilly, 119 F.3d at 1569. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus. See Rochester, 358 F.3d at 927.
Thus, case law dictates that to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the claims is a functional characteristic, i.e., the ability to bind and decrease the activity of Siglec 15, and the ability to have a desired effect on cancer. There is not even identification of any particular portion of a structure that must be conserved. Not a single species of the encompassed genus is described in the specification with regard to its precise structure. Rather, the specification provides methods of screening for antagonistic antibody products. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of antibody products recited in the claims.
Regarding structure-function correlation more specifically, it is noted that one of skill in the art was aware that there is a lack of structure-function correlation in antibody molecules. Evidence of such in the form of publications in the art include the following.
First, the prior art recognizes that the full six CDR sequences are required to form the part of an antibody, i.e., the paratope, that specifically binds the target antigen. See Al Qaraghuli et al. (2020, Nature Scientific Reports 10:13969), who state that the six CDRs form a continuous surface to form the paratope that binds the epitope of the cognate antigen.
However, the prior art also recognizes that a single protein can be bound by a very large and structurally diverse genus of antibodies (i.e., there is no common structural relationship even for antibodies that bind to the same protein, epitope, or overlapping epitopes). For example, Edwards et al. (2003, JMB 334:103-118) teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences, and representative of almost the entire extensive heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines), and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well.
Lloyd et al. (2009, Protein Engineering, Eng. Design & Selection 22(3): 159-168) teach that a large majority of VH/VL germline gene segments are used in the antibody response to an antigen, even when the antibodies were selected by antigen binding. Said reference further teaches that in their studies, of the 841 unselected and 5,044 selected antibodies sequenced, all but one of the 49 functional VH gene segments was observed, and that there are on average about 120 different antibodies generated per antigen. Said reference also teaches that a wide variety of VH and VL pairings further increase diversity. (See entire reference.)
Goel et al. (2004, J. Immunol. 173: 7358-7367) teach that three mAbs that bind to the same short (12-mer) peptide, exhibit diverse V gene usage, indicating their independent germline origin. Said reference further teaches that two of these mAbs recognize the same set of amino acid residues defining the epitope (alternate amino acid residues spread over the entire sequence), however, the relative contribution of each set of residues in the peptide showed significant variation. The reference notes that all of the mAbs do not show any kind of V gene restriction among themselves, implying variable paratope structure, despite that two of these mAbs bind to the peptide through a common set of residues. (See entire reference).
Khan et al. (2014, J. Immunol. 192: 5398-5405) teach that two structurally diverse germline mAbs recognizing overlapping epitopes of the same short peptide do so in different topologies, the antibodies possessing entirely different CDR sequences. Said reference teaches that unrelated mAbs structurally adjust to recognize an antigen, indicating that the primary B cell response is composed of BCRs having a high degree of structural adaptability. Said reference also teaches that the common epitope(s) also adopt distinct conformations when bound to different mAbs, with the higher degree of structural plasticity inherent to the mAbs. Said reference further teaches “It has been shown that both the framework region and the CDRs have a considerable amount of inherent conformational plasticity...Therefore, it is not surprising that distinct germline Abs recognize the same epitope by rearranging the CDR conformations. This may well have implications of Ag specificity beyond the naive BCR repertoire, because Kaji et al... .have shown in a recent report that the B cell memory can contain both germline-encoded and somatically mutated BCRs.” (See entire reference).
Poosarla et al. (2017, Biotechn. Bioeng. 114(6): 1331 -1342) teach substantial diversity in designed mAbs (sharing less than 75% sequence similarity to all existing natural antibody sequences) that bind to the same 12-mer peptide, binding to different epitopes on the same peptide. Said reference further teaches “most B-cell epitopes... in nature consist of residues from different regions of the sequence and are discontinuous...de novo antibody designs against discontinuous epitopes present additional challenges...". (See entire reference.)
Rabia, et al. (2018, Biochemical Engineering Journal 137:365-374) teach what effects mutations can have on an antibody's stability, solubility, binding affinity and binding specificity. Rabia et al. report that an increase in antibody affinity can be associated with a decrease in stability (p. 366, col. 2 last paragraph; Fig. 2). Rabia et al. thus teach that affinity and specificity are not necessarily correlated and that and increase in affinity does not indicate an increase in specificity (Fig. 3; p. 368, col. 1, section 3,1st full paragraph to col. 2, 2nd full paragraph).
Conversely, evidence also shows that some functionally diverse antibodies can share some structural similarities, including an entire CDR region. See Igawa et al. (US 9,334,331 B2), who disclose antibody Q153 that binds human Factor IXa. Q153 comprises a VH-CDR1 identical to the VH-CDR1 of antibody 11E12 disclosed by Gonzales et al. (US 10,421,807 B2). However, 11E12 specifically binds canine IL-31, a protein having no structural or functional similarity to human Factor IXa. This illustrates that even when some CDR regions share 100% structural identity, the antibodies in which they are comprised can have completely different functions (i.e., binding specificities).
The combination of evidentiary publications thus underscores a lack of structure-function correlation in antibody molecules.
Regarding a representative number of species more specifically, the instant specification fails to describe a representative number of species to provide adequate written description of the claimed genus as per MPEP § 2163. While reference is made to Siglec 15 antibodies by name or other patent documents that disclose Siglec 15 antibodies (e.g., pp. 46-47), the only substantive information on antibody products that have the required activity on cancer are provided in the working examples, wherein anti-Siglec 15 antibody “m01” was shown to have an effect on colon adenocarcinoma. However, there is no description of the structures of even this preferred antibody product. Not a single species of antibody product is described with sufficient identifying characteristics using precise definitions such as structure, formula, chemical name, or physical properties such that one skilled in the art could visualize or recognize the identity of the claimed subject matter.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), 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). However, in the instant case the skilled artisan cannot envision the detailed chemical structure of the encompassed antibody products, 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 isolating it. 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 (Fed. Cir. 1991).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483 (BPAI 1993). 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’s attention is directed to the recent decision in Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The court discussed whether an antibody is adequately described by describing a newly characterized antigen. Specifically, the court referred to the decision in Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011). In that case, the patentee claimed a genus of antibodies containing a human variable region that has particularly desirable therapeutic properties: high affinity, neutralizing activity, and A2 specificity. Despite the fact that the specification disclosed human TNF-α protein, and despite the disclosure of the structures of more than one species of antibody related to the genus, the court ruled that that the generic antibody claims at issue were invalid for lack of written description. The fact pattern is similar in the instant case, although in this case there is no description of the structure of a single antagonist antibody recited by the claims. As in the court case, the instant claims recite a genus of antibodies that have affinity for those antigens and have a desirable therapeutic property, i.e., antagonizing activity and the ability to inhibit binding of sclerostin to LRP. Following the finding in Centocor, the instant claims are found to lack adequate written description.
The court in Amgen v. Sanofi further compares the requirements of enablement and written description, stating that:
“We cannot say that this particular context, involving a “newly characterized antigen” and a functional genus claim to corresponding antibodies, is one in which the underlying science establishes that a finding of “make and use” (routine or conventional production) actually does equate to the required description of the claimed products. For us to draw such a conclusion, and transform a factual issue into a legally required inference, we would have to declare a contested scientific proposition to be so settled as to be entitled to judicial notice. That we cannot do.”
The court indicated that it has been hotly disputed whether or not knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. Citing Centocor again, the court provides an analogy for the antibody-antigen relationship as not quite a lock and key relationship but rather providing a lock and then searching for a key on a ring with a million keys on it. The court concludes that the “newly characterized antigen” test flouts basic legal principles of the written description requirement, reasoning that section 112 requires a written description of the invention, whereas the newly characterized antigen test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The court urges that such constricts the “quid pro quo” of the patent system where one describes an invention in order to obtain a patent.
Similarly, in Juno Therapeutics, Inc., Sloan Kettering Institute for Cancer Research v. Kite Pharma, Inc. (Case 2020-1758, CAFC August 2021), the court found that the disclosure of two antibody products (scFv molecules) was insufficient to support written description for the claimed genera, specifying that the specification at issue failed to disclose “structural features common to the members of the genus to support that the inventors possessed the claimed invention;” i.e., the specification and evidence of record failed to provide a structure-function correlation. In the instant case, there is also no evidence of a structure-function correlation for antibodies, and thus the claims are properly rejected for lack of adequate written description.
Finally, for a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding), “[claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
Applicant’s arguments (pp. 5-9, remarks received 03 March 2025) have been fully considered but are not found to be persuasive for the following reasons.
Applicant refers to Example 7 of a presentation dated 17 September 2020 pertaining to guidance about antibodies and written description under 35 U.S.C. 112(a). Applicant argues that, like in the example, there is evidence that inhibiting the activity of Siglec15 with various Siglec 15 targeted therapeutic agents results in reduction of tumor size and/or affected immune response at the tumor site. Specifically, Applicant points to Example 17 as showing that decreasing levels or activities of Siglec 15 reduced tumor size and prolonged survival of mice having colon tumors. Applicant points to Example 18 as showing reduction in tumor size after treatment with an antagonistic antibody for Siglec 15. Applicant further points to Example 15 as showing that blockade of Siglec 15 by Siglec 15-Fc treatment reduced tumor size in a mouse brain tumor model and worked synergistically with anti-PD-L1 antibody. Applicant points to Example 16 as showing enhanced immune response at the tumor site in Siglec 15 knockout mice as compared to the immune response at tumors in WT mice.
This has been fully considered but is not found to be persuasive. MPEP § 2163(II)(A)(3)(a)(ii) indicates that the written description requirement for a claimed genus may be satisfied through description of a representative number of species or disclosure of relevant, identifying characteristics, or by functional characteristics coupled with a known or disclosed correlation between structure and function. Example 7 invoked by Applicant speaks to a representative number of species and functional characteristics. While the specification examples referenced by Applicant in the remarks support the notion that inhibition of Siglec 15 function by various types of molecules reduces tumor size and enhances immune response at a tumor site in colon and brain tumors, the claims recite treatment of any cancer in the broadest claims, and treatment of brain, lung, head and neck, and breast cancer in the narrowest claims. There is a lack of correspondence between the functions required by the claims and the types of cancers which were shown to benefit from inhibition of Siglec 15 activity in the specification as originally filed. This is in contract to guidance example 7, wherein the claims are limited to treatment of only one specific disease, i.e., high blood pressure.
Applicant also discusses guidance example 7 as establishing that adequate written description for a genus recited in the claims can be established by a representative number of species described in the specification and/or the prior art. Applicant points to the instant specification at pp. 46-47. Applicant further points to the specification’s discourse of methods of making and screening for antagonist Siglec 15 antibodies.
This has been fully considered but is not found to be persuasive. The paragraph bridging pp. 46-47 of the specification refers to antibodies S15m03 and S15M02 “described herein.” However, the specification never provides structures or a biological deposit for these antibodies, and thus these antibodies cannot be relied upon as supporting the claimed genus. At p. 47, lines 3-5, the specification points to an antibody disclosed in US Provisional Application No. 62/397,794, filed 21 September 2016. However, this provisional application was filed after the earliest claimed priority data of the instant application (10 November 2015), and also cannot be relied upon as a species of the claimed genus. At p. 47, lines 6-17, the specification points to five antibodies disclosed in other prior patent documents. These can be relied upon as species. However, it is held that the five species are not representative of the entire genus as claimed. The claims encompass a large genus of any antagonistic antibody or antigen binding fragment thereof, wherein the antibody product binds Siglec 15 (of any structure, and from any source), and inhibits Siglec 15 activity. The five prior art antibodies are considered to fall within this genus. However, the courts have found that description of a few antibodies is not representative of a claimed genus of antibodies. See Juno Therapeutics, Inc., Sloan Kettering Institute for Cancer Research v. Kite Pharma, Inc. (Case 2020-1758, CAFC August 2021), wherein the court found that the disclosure of two antibody products (scFv molecules) was insufficient to support written description for the claimed genera, specifying that the specification at issue failed to disclose “structural features common to the members of the genus to support that the inventors possessed the claimed invention;” i.e., the specification and evidence of record failed to provide a structure-function correlation. In the instant case, there is also no evidence of a structure-function correlation for antibodies, and thus the claims are properly rejected for lack of adequate written description.
Regarding the specification’s described methods for making and screening antibodies within the recited genus, it is noted that the courts have found that adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. 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 (Fed. Cir. 1991).
Finally, Applicant argued that the claims are not directed to antibody products, but to methods of utilizing the antibodies. Applicant asserts that as a result the claims recite functional limitations that can be tested and confirmed by routine experimentation. Applicant urges that the claimed methods are not necessarily predicated on the structure of the antibodies but instead on the ability of the antagonistic antibodies to bind and decrease the activity of Siglec 15.
This has been fully considered but is not found to be persuasive. The issues discussed by Applicant are more relevant to enablement than to written description. Whereas enablement is a question of law wherein factors such as amount of experimentation must be weighed and considered, the requirement for adequate written description is a question of fact. Are the claims adequately described by the specification? MPEP § 2163(II)(A)(3)(a)(ii) indicates that the written description requirement for a claimed genus may be satisfied through description of a representative number of species or disclosure of relevant, identifying characteristics, or by functional characteristics coupled with a known or disclosed correlation between structure and function. Neither the MPEP nor the relevant case law make a distinction between claims directed to products and methods of using products when a genus is recited in the claims. For example, the claims at issue in In re Alonso (545 F.3d 1015 (Fed. Cir. 2008) were directed to methods of using antibodies wherein the court found that the claims lacked adequate written description for the recited genus of antibodies recited in the methods. Also, it is noted that Example 6 of the written description guidelines 2020 pertains to a method of using a genus of antibodies wherein the method of use claim is indicated as lacking adequate written description.
For all of these reasons, the rejection is maintained.
Applicant’s Arguments
Applicant urges that the specification’s working examples provide sufficient evidence to support the correlation between decreasing levels or activities of Siglec 15 and treating cancer, reducing tumor size, and enhancing immune response, as claimed.
Applicant has referred examples of the “Antibodies and the Written Description Requirement of 35 U.S.C. 112(a) Guidance issued on September 17, 2020 by the USPTO. Applicant urge that have demonstrated, in colon cancer model, that tumors derived from cell expressing Siglec 15 were larger than tumors derived from cells lacking Siglec 15 expression and the tumor size was significantly reduced in mice treated with an antagonistic antibody.
Applicant urges that the claims are not directed to anti-Siglec 15 antibodies themselves, but instead are directed to methods of utilizing those antibodies.
Response to Applicant’s Arguments
This has been fully considered but is not found to be persuasive. As Applicant states, the claims have been amended to recite administration of “an antagonist antibody for Siglec 15” or an antigen-binding fragment thereof “that decreases the expression and/or activity of Siglec 15 in the subject.” The specification indicates at page 18 that a modulator of Siglec 15 can modulate the expression and/or activity of Siglec 15 either directly or indirectly, stating that, for example, the modulator can act through a binding partner of Siglec 15. At page 19, the specification indicates that an “inhibitor of Siglec 15” or a “Siglec 15 antagonist” can act through inhibition/antagonism of Siglec 15 itself, or inhibition/antagonism of a ligand of Siglec 15 such as MAG, LRRC4C, or Sialyl-Tn. Accordingly, the claims encompass use of a much larger genus of antibodies than that discussed by Applicant. This larger genus includes, for example, antibodies that bind Siglec 15 ligands (thus affecting Siglec 15 activity) or antibodies that bind transcriptional regulators of Siglec 15 (thus affecting Siglec 15 expression). This is not the scenario presented by Example 7 of the written description guidelines (2020) discussed by Applicant, and therefore rejection of the claims for lack of adequate written description is appropriate.
Regarding the claims being directed to methods of use rather than to antibody products, it is noted that there is no distinction between claims directed to methods of use or products. Both require adequate written description of the genus of antibodies recited in the claims. For example, Example 6 of the written description guidelines 2020 pertains to a method of using a genus of antibodies wherein the method of use claim is indicated as lacking adequate written description. Also, the claims at issue in In re Alonso (545 F.3d 1015 (Fed. Cir. 2008) were directed to methods of using antibodies wherein the court found that the claims lacked adequate written description for the recited genus of antibodies recited in the methods.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-9, 11-15, 17, and 18 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Tremblay et al. (US 2013/0039915 A1; published 14 February 2013; effectively filed 18 September 2012).
Tremblay et al. teach a method of treating a cancer in a subject in need thereof, comprising administering an antagonist antibody, or antigen-binding fragment thereof, that binds Siglec 15 and decreases the activity of Siglec 15 in the subject, thereby treating the cancer in the subject. See abstract, [0032], [0033], [0578], [0641]. This anticipates claim 1.
Regarding claim 2, treatment of breast cancer and lung cancer is taught at [0033].
Regarding claim 3, treatment of humans is taught at [0550], [0569].
Regarding claims 5 and 6, Tremblay et al. teach that their antibody blocks the interaction between Siglec 15 and sialic acids at [0032]. This provides evidence that the antibody can block interaction at least between Siglec 15 and sialyl-Tn. Tremblay et al. acknowledge that sialyl-Tn is a preferred ligand for Siglec 15 at [0015].
Applicant’s Arguments
Applicant urges that the claims have been amended to a method of treating a solid tumor cancer in a subject in need thereof, comprising administering an antagonist antibody or antigen-binding fragment thereof, that binds Siglec 15 and decreases the activity of Siglec 15 in the subject, thereby treating the cancer in the subject.
Applicant urges that Tremblay teaches the use of anti-Siglec 15 antibodies in the treatment of bone-related disease such as bone loss and osteoporosis. Applicant urges that Trembley fails to teach or suggest a modulator of Siglec 15 for use in reducing a tumor size, and /or increasing an immune response against a tumor in a subject as required by the claims.
Response to Applicant’s Arguments
This has been fully considered but is not found to be persuasive. It is understood that the claims have been amended to a solid tumor. Tremblay et al teach method of detecting and treating bone loss, bone-related disease or cancer using the antibodies and fragments are disclosed (see the Abstract and [0033]). Tremblay et al teach antibodies or antigen binding fragments of the present invention may also be useful for treating bone loss, ovarian cancer, renal cancer, cancer of the central nervous system, prostate cancer, melanoma, breast cancer, lung cancer or colon cancer [paragraph 0033]. Breast, lung and colon cancer are all examples of solid tumor cancers. Tremblay et al teach the antibodies of the invention binds to Siglec-15 [0298]. Tremblay et al teach that the antibodies and antigen-binding fragments of the invention may block the biological activity of Siglec-15 (see the Abstract), thereby decreasing the activity of Siglec 15 in the subject. Additionally, Tremblay et al teach that FIG. 15 shows an ELISA that demonstrates that the anti-Siglec antibodies can inhibit the interaction between Siglec and sialic acids [0032].Tremblay et al teach anticipate the claimed invention.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
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/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674