DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 8/13/25 has been entered in full:
---The specification is amended. It is noted that in the title as amended the word “Damages” (plural) has been changed to “Damage” (singular) despite a lack of markings indicating the change. The amended title is entered but Applicants should confirm that this change was intended, or else amend the title further to restore the plural form.
---Claims 1, 3-6, 9-14 and 16 are amended. Claims 2, 15 and 17 are canceled.
---Claims 1, 3-14, 16 and 18-20 are pending.
Applicants' election without traverse of Group I, drawn in the alternative to a method of contacting T cells with a CD84 inhibitor that is in antibody, either in vivo or in vitro, was previously acknowledged. Independent claims 1 and 14 are now amended to limit the CD84 inhibitor to an anti-CD84 antibody, and therefore claims 1, 4-14, 18 and 19 are no longer linking claims but are instead directed to the subject matter of Group I. As such, Group I is now claims 1, 3-14 and 18-20. Claim 16 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group V), there being no allowable generic or linking claim.
The election of “cerebral vascular ischemia” as the species of “ischemic disease or tissue damage” was also previously acknowledged. Claims 8 and 18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1, 3-7, 9-14 and 19-20 are under consideration, as they read upon the elected species.
Information Disclosure Statement
The Information Disclosure Statement of 8/13/25 has been considered.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (5/13/25).
The second ground of objection to the specification at pages 2-3 is withdrawn in view of the amendments to the specification. The first ground is maintained (see below).
All rejections of canceled claims 2, 15 and 17 are moot.
The rejection of claims 1, 7, 9-11, 13 and 19-20 at pages 8-9 under 35 U.S.C. 102(a)(1) as being anticipated by Hofmann (2013) is withdrawn in view of the amendments to the claims that limit the administered CD84 inhibitor to an antibody, which is not taught by Hofmann.
The rejection of claim 14 at page 10 under 35 U.S.C. 102(a)(1) as being anticipated by Cannons et al (2010) is withdrawn in view of the amendments to the claims to limit the T cells to human T cells, which are not taught by Cannons.
The rejection of claims 2-6, 12 and 17 at pages 11-13 under 35 U.S.C. 103(a) as being unpatentable over Hofmann (2013) and further in view of Shachar, U.S. 2017/0260270 (9/14/17) is withdrawn in view of Applicants’ persuasive arguments at pages 11-14 of the 8/13/25 reply.
Maintained Objections and/or Rejections
Specification
In the previous Office action, mailed 8/13/25, the disclosure was objected to at pages 2-3 for having a title that was not descriptive because it was directed to any form of treatment of ischemic disease, but the claimed method was limited to administration of a CD84 Inhibitor. In response, Applicants have amended the title of the specification to limit it to add, “with a CD84 Inhibitor”. However, the claimed invention has also been amended to change the CD84 Inhibitor to an anti-CD84 antibody, which is narrower structurally, but also broader functionally as it encompasses agonist antibodies. Thus, the objection is maintained because the amended title is not descriptive because it does not correspond to what is claimed. It is suggested that “with a CD84 Inhibitor” be amended to “with an anti-CD84 Antibody” to reflect the claimed invention.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), written description
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 1, 3-7, 9-13 and 19-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The rejection was set forth at pages 3-7 of the 5/13/25 Office Action.
The claims have been amended to change the CD84 inhibitor to an anti-CD84 inhibitor. The scope of this differs in that structures other than antibodies are excluded. Thus, the portion of the rejection directed to inhibitors other than antibodies is now moot.
However, with respect to antibodies, the scope is broader in that it encompasses antibodies that are inhibitors, non-inhibitors or activators, i.e., agonist antibodies. The specification at page 4 teaches, “An antibody that binds to CD84 (anti-CD84 antibody) may be an inhibitor or a non-inhibitor. It is only an inhibitor if it induces the partial or complete suppression, inhibition or blocking of the expression, activity or interaction of CD84 (blocking antibody)” (lines 14-17). However, the specification fails to provide any examples of the structures of anti-CD84 antibodies that are non-inhibitors or agonists of CD84. Furthermore, the specification further indicates that non-blocking anti-CD84 antibodies will not block the migration of T cells (page 35, lines 7-8), indicating that these antibodies would not function in the claimed therapeutic method. As such, the portion of the scope of “anti-CD84 antibody” encompassing these non-inhibitors and agonist antibodies lacks written description. Furthermore, the rejection of the claims based on inhibitory anti-CD84 antibodies set forth previously is maintained for the reasons of record.
Applicants’ arguments (8/13/25; pages 6-9) as they pertain to the rejection have been fully considered but are not deemed to be persuasive for the following reasons.
At page 7, Applicants argue that the rejection is moot in view of the amendments to the claims that change the administered CD84 inhibitor to an anti-CD84 antibody. Applicants argue that the case law cited in the rejection “pertains to the discovery of novel antibodies or other novel molecules, whereas the present claims pertain to new uses of known antibodies” (page 7), whereas the claimed methods “encompass the use of antibodies that are already known in the art” (page 8). Applicants argue that the courts have instead “emphasized that the specification need not recite structures of the exemplary molecules” (page 8), pointing to Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co. (E.D. Tx. 2017) in support. Applicants argue that “there were several known examples of anti-CD84 antibodies with the scope of claim 1 in the prior literature”, pointing to the “B1, B4, and F8 antibodies set forth in the WO2010035259, WO2015118538, and WO2017118985, as well various commercially available CD84 antibodies such as ab131256 (Abcam), AB_914342 (ThermoFisher), AB_324419 (Bio-Rad), and AB_1036230 (Miltenyi Biotec)” (page 8). Applicants argue “representative species of anti-CD84 were well-known at the time of filing” and as such “there was no need to provide further description of antibodies that would have already been well-known to one of ordinary skill in the art at the time of filing to fulfill the written description requirement” (page 8). Applicants point to MPEP 2160.01 as stating that “a “patent need not teach, and preferably omits, what is well known in the art” (page 9). Applicants further describe the working examples in the specification and they “would have clearly guided one of ordinary skill in the art to be able to practice the disclosed methods using any one of the antibodies previously disclosed in the art” (page 9).
Applicants’ arguments have been fully considered but are not found persuasive for the following reasons. The rejection of record acknowledged that the inhibitory anti-CD84 antibodies B1 and B4 were known in the prior art, citing U.S. 20170260270 (cited previously), but held that a description of two species was not sufficient to be representative of a genus encompassing hundreds or thousands of members. The F8 antibody cited by Applicants is herewith acknowledged as another example of an inhibitory anti-CD84 antibody known in the prior art. The ‘270 publication describes it as a “blocking antibody described in the art”, citing the WO2010035259 publication. With respect to the “various commercially available CD84 antibodies”, Applicants do not provide any supporting evidence that these antibodies were available prior to the claimed priority date of the instant application (7/1/19). Furthermore, there is no indication whether or not these commercially available antibodies were inhibitory and thus functional with respect to the claimed method. Thus, there is no evidence of record that these antibodies were well known in the prior art as inhibitory anti-CD84 antibodies. As such, while there is evidence of three inhibitory antibodies (B4, B1, and F8) were known in the prior art, a description of two species is not sufficient to be representative of a genus encompassing hundreds or thousands of structures of antibodies, some of which are inhibitory, non-inhibitory or agonistic. Thus, the assertion that the genus of therapeutic compound to be administered, i.e., “an anti-CD84 antibody”, was well known in the prior art is not found to be persuasive. Per MPEP 2163, "A "representative number of species" means that the species which are adequately described are representative of the entire 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.
Thus, the claims under consideration in the decision of “UroPep” are distinguished from the instant claims, because in UroPep, the genus of PDE5 inhibitors were held to be sufficiently described by the prior art (“Given the evidence of the knowledge of a person of skill in July 1997 regarding PDE5 inhibitors, including tadalafil, a reasonable jury could have found that the specification disclosed a sufficient number of representative species of selective PDE5 inhibitors”; page 15 of UroPep), but the instant application, the genus of anti-CD84 antibodies described by the prior art are not.
Furthermore, the CAFC has held that method claims directed to composition that is not described are also subject to the written description requirement. Per MPEP 2163:
“See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").”
See also Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149 (Fed. Cir. 2019), where method claims directed to use a genus of compounds were “held invalid for lack of written description, as [failing] to provide sufficient blaze marks to direct a POSA [person of ordinary skill in the art] to the specific subset of 2'-methyl-up nucleosides that are effective in treating HCV [hepatitis C virus]” (page 23). Thus, it is maintained that is appropriate to make a written description rejection over method claims directed to a genus of compounds itself failing to comply with the requirements for written description.
New rejections necessitated by Applicants’ IDS
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-7 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2017/118985, published 7/13/17 (cited on the 8/13/25 IDS). The earliest date to which the instant application claims priority is 7/1/19.
This rejection is necessitated by the IDS filed on 8/13/25, which cites the ‘985 publication as reference 3 in the “Foreign Patent Documents” section.
As amended, claim 1 encompasses a method for treating an ischemic disease by administering an anti-CD84 antibody to a subject in need thereof.
‘985 teaches “a use of a therapeutically effective amount of an agent capable of decreasing an activity or expression of CD84 for treating an autoimmune or inflammatory disease in a subject in need thereof” (page 6, lines 8-11). The examples of autoimmune diseases to be treated include cardiovascular diseases (page 64, lines 5-6), and the examples of autoimmune cardiovascular diseases to be treated include several that are recited in dependent claim 7, and thus are encompassed by claim 1: atherosclerosis, myocardial infarction and vasculitis (page 64, lines 10-16). ‘985 further teaches that “the agent capable of decreasing the activity or expression of the CD84 is an antibody” (page 8, lines 22-23), including those that bind to the extracellular domain of ‘985 (page 8, lines 24-25). As such, ‘985 teaches a method for treating an ischemic disease by administering an anti-CD84 antibody, and therefore the teachings of ‘985 anticipate claim 1.
Claim 3 encompasses a method of claim 1 wherein the antibody is in a form selected from a group including a humanized antibody. ‘985 further teaches that antibodies of the invention can be humanized (page 29, line 20). As such, the teachings of ‘985 also anticipate claim 3.
Claims 4-6 each depend from claim 1 and further limit the antibody by means of further functional limitation: to one that “inhibits homotypic receptor interaction and/or dimerization of CD84 molecules” (claim 4), “inhibits the interaction of a CD84 molecule on T cells with another CD84 molecule derived from platelets” (claim 5), or “binds to the domain of CD84 that mediates homotypic receptor interaction” (claim 6). ‘985 further provides specific examples of antibodies to be used, include one designated “F8” (page 31, lines 6-11). This antibody would inherently possess the further functional limitations of claims 4-6, as evidenced by Applicants’ reply at page 8, which points to the F8 antibody as an example of an antibody encompassed by the instant claims. As such, the teachings of ‘985 also anticipate claims 4-6.
Claim 7 encompasses a method of claim 1 wherein the ischemic disease is selected from a group including atherosclerosis, myocardial infarction and vasculitis, which are anticipated by ‘985 for the reasons set forth above for claim 1.
Claim 9 encompasses a method of claim 1 wherein the anti-CD84 antibody is administered to the subject prior to ischemia. ‘985 further teaches that the term treating includes “substantially preventing the appearance of clinical or aesthetical symptoms of a condition” (page 78, lines 6-9), which encompasses treatment prior to the occurrence of the disease; e.g. myocardial infarction. As such, the teachings of ‘985 also anticipate claim 9.
Claim 10 encompasses a method wherein the anti-CD84 antibody is administered to the subject after ischemia. ‘985 further teaches that the subject can be “diagnosed with an autoimmune or inflammatory disease (e.g., prior to treatment)” (page 69, lines 3-4). As such, the treatment is made after the occurrence of the disease; e.g., after myocardial infarction has been diagnosed. As such, the teachings of ‘985 also anticipate claim 10.
Claims 11 and 13 each encompass a method of claim 1 further limited by a wherein clause indicating that the method inhibits or suppresses T cell migration. In each claim, the wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, each wherein clause simply express the intended result (inhibition or suppression of T cell migration) of a process step positively recited (administration of a CD84 inhibitor). As such, the teachings of ‘985 that anticipate claim 1 also anticipate dependent claims 11 and 13 because, in each case, the further wherein clause does not render the claim patentably distinct from the teachings of ‘985 that anticipate claim 1.
Claim 12 encompasses a method of claim 1 wherein the method further comprises administering another therapeutic agent. ‘985 further teaches, “According to another embodiment, in order to enhance treatment of the autoimmune disease or inflammatory disease, the present invention further envisions administering to the subject an additional therapy which may benefit treatment. One of skill in the art is capable of making such a determination” (page 76, starting at line 31). As such, the teachings of ‘985 also anticipate claim 12.
Claim 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tangye et al, 2003. J Immunol 171(5): 2485-2495 (cited on the 8/13/25 IDS). The earliest date to which the instant application claims priority is 7/1/19.
This rejection is necessitated by the IDS filed on 8/13/25, which cites Tangye as reference 11 in the “Non-Patent Literature Documents” section.
Claim 14 has been amended to limit the T cells to human T cells, and to change the CD84 inhibitor to an anti-CD84 antibody.
In independent claim 14, the recitation of “for inhibiting CD84 T cell migration in vitro” has been considered in the context of the entire claim, and is interpreted as an intended use for the method because it does not result in a manipulative difference between the method as defined by the steps and a prior art method teaching the same steps. See MPEP 2111.02. As such, this intended use does not distinguish the claimed method from a prior art method comprising the same step. Thus, claim 14 as amended encompasses a method comprising a step of contacting human T cells with an anti-CD84 antibody in vitro.
Tangye teaches human T cell lines including F2F7 and freshly isolated human T cells (page 2486, “Cells and cell lines”) and an anti-CD84 antibody (page 2486, “Antibodies”). Tangye further teaches contacting the human T cell lines or freshly isolated T cells with said anti-CD84 antibody (e.g., page 2486, 2487, 2489). As such, Tangye teaches an in vitro method of contacting human T cells with an anti-CD84 antibody, and therefore anticipates claim 14 as amended.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p) on 12/06/2024 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674