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 .
Response to Amendment
The Amendment filed May 5, 2026 in response to the Non-final rejection of January 7, 2026 is acknowledged and has been entered.
Claims 1-9 were amended or previously presented. Claim 11 was newly added.
Claims 1-9, and 11 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Drawings/Brief Description of Drawings
The objection to Figure 2D is withdrawn in view of applicant’s amendment to the specification.
Claim Objections
The objection to Claim 5 is withdrawn as applicants state that a “peptide” is structurally distinct from a “polypeptide”. Applicants argue that peptides refer to short, linear chains (2-50 amino acids) compared to the longer chains associated with polypeptides. This argument has been considered and is found persuasive.
Rejections Withdrawn
The rejections of Claim 9 and 5 under 35 U.S.C. 112(b) are withdrawn in view of applicant’s amendments and arguments thereto. 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.
The rejection of claims 1-10 under 35 U.S.C. 102(a)(1) as being anticipated by Liaudet-Coopman et al. (US 2018/0127510, published May 10, 2018) are withdrawn in view of applicant’s amendment.
The rejection of claims 1-5, and 9-10 under 35 U.S.C. 102(a)(1) as being anticipated by Al-Murrani et al. (US 2005/0176669, published August 11, 2005) are withdrawn in view of applicant’s amendment.
The rejection of Claims 1-10 on the grounds of nonstatutory double patenting as being unpatentable over claims 1-4, 15-16 of U.S. Patent No. 10,526,415 are withdrawn in view of applicant’s amendment.
Rejections Maintained
Claim Rejections - 35 USC § 112
Claims 1-9 remain rejected and new claim 11 is 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 for the reasons of record in the non-final action mailed 01/07/2026 (para 13-20) and for the reasons set forth herein.
Applicants argue (Remarks, 05-05-2026, pages 6-7) that independent claim 1 is amended to clarify that a “direct” SPARC inhibitor is administered to the subject and that new claim 11 specifies that the inhibitor is an antibody. Applicants further refer to MPEP 2163 and note that the Federal Circuit has stated that examples are not necessary to support the adequacy of a written description and that the written description standard may be met even where actual reduction to practice of an invention is absent; and that there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure. Applicants further emphasize case law stating what is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. The above arguments by applicants appear to justify the allegation that “direct SPARC inhibitors are known in the art and thus the application does not need to describe such inhibitors in detail”. Applicants further have provided a printout of evidence that known SPARC antibodies can be purchased and thus are well known.
These arguments have been considered but are not found persuasive. The written description rejection was not solely based upon whether or not direct SPARC inhibitors are known in the art but rather to the entire scope of the claimed invention and whether or not applicants have demonstrated possession of treating cancer in a subject with any and all SPARC inhibitor fragments. In their arguments, applicants do not address the written description of SPARC inhibitors in conjunction with treating cancer; and, treating cancer with a genus of SPARC inhibitors, does not appear to be well known nor conventional as of the filing date. Previously, the written description and state of the prior art only set forth anti-Cath-D antibodies and specific siRNAs for treating cancer in a subject. However, now that applicants have amended Claim 1 to “direct” SPARC inhibitors, the written description has shifted to whether or not there the specification provides an adequate written description of treating cancer with SPARC inhibitors that interact directly with SPARC (SPARC is also known as osteonectin or BM40- specification, para 0003).
In the instant case, the inventors have not demonstrated possession of any direct SPARC inhibitors. The summary of the invention [0006] indicates that the inventors demonstrated that the matricellular protein SPARC is an extracellular cath-D (lysosomal aspartic protease cathepsin-D) substrate which induced limited proteolysis of SPARC. The limited proteolysis of SPARC, in turn, produced SPARC fragments- such as those claimed in claim 2. Thus, these are fragments that are indirectly produced as a result of enzymatic cleavage of the SPARC protein. It is these fragments which appear to be used to inhibit the growth of cancer [see Cath-D-Induced SPARC Fragments Inhibit TNBC Cell Adhesion and Spreading, and Promote their Motility, Endothelial Transmigration and Invasion- 0107]. The inhibitors of these fragments [0022] represent the genus as previously claimed wherein an “inhibitor of SPARC fragment” refers to a natural or synthetic compound able to inhibit the activity of the SPARC fragment and selectively blocks or inactivates SPARC fragment. As used herein, the term “selectively blocks or inactivates” refers to a compound that preferentially binds to and blocks or inactivates SPARC fragment with a greater affinity and potency, respectively, than its interaction with Cath-D.
However, the scope of the invention has shifted to no longer encompass administering inhibitors of SPARC fragments but to the administration of direct inhibitors of the SPARC protein itself for the purposes of treating cancer and there is no guidance or written description for administering a direct inhibitor of SPARC whether it be an antibody, aptamer, peptide, polypeptide, or small molecule organic compound. Further, there is no written description for a direct SPARC inhibitor that “inhibits production” of a SPARC fragment. What applicants seem to be in possession of are cath-D induced SPARC fragments (e.g., those in claim 2) that can be administered for the treatment of triple negative breast cancer. Thus, the written description is maintained.
New Rejections
Claims 1-9, 11 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. This is a NEW MATTER rejection.
Amended claim 1 is drawn to treating cancer in a subject comprising administering “a direct SPARC inhibitor”. The broadest reasonable interpretation is administering a drug or agent that directly interacts with the SPARC protein. As to claim 2, the broadest reasonable interpretation is that by administering the direct SPARC inhibitor to the subject with cancer, SPARC fragments would be naturally created in vivo. However, as set forth above, and herein, there is no clear support in the specification and the claims as originally filed for the newly claimed subject matter. Applicant is required to cancel the new matter in the response to this Office Action. Alternatively, applicant is invited to provide sufficient written support for the newly amended claims. See MPEP 2163.06
Claim(s) 1-7, 9, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trieu, V. (US 20120014954, Jan 19, 2012).
Trieu, V. teaches [0181] a method of treating cancer in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a SPARC binding peptide-Fc fusion agent. The specification teaches [0004] that SPARC is a Ca2+-binding glycoprotein that regulates extracellular matrix assembly and deposition, growth factor signaling, and interactions between cells and their surrounding extracellular matrix. Since the specification does not specifically define what encompasses a SPARC inhibitor (it only defines an “inhibitor of SPARC fragment”), the broadest reasonable interpretation of a direct SPARC inhibitor is anything that directly binds to SPARC. Thus, the peptide-FC fusion agent taught by Trieu, V. is a species of such an inhibitor as it directly binds SPARC and facilitates the inhibition of cancer cell growth in vivo [0191]. Accordingly, since the product of the prior art is identical to that which is claimed and is administered in vivo, any biological effects claimed would also naturally occur and be anticipated such as the inhibition of SPARC fragment production (Claim 2), the inhibition of the production of the C-terminal 9-kDa SPARC fragment and associated peptides (Claims 3-4). It is further noted that the specification defines the term antibody [0029] and includes polyclonal and monoclonal antibodies, and monovalent and divalent fragments thereof. Furthermore, “antibody” includes chimeric antibodies, wholly synthetic antibodies, single chain antibodies, and fragments thereof. The direct SPARC binding agent of the prior art (Figure 1) appears to encompass a synthetic antibody as it has an antigen recognition domain, a hinge region, and an Fc domain. The reference further teaches [0153] that one of the preferred cancers is breast cancer and that the methods of the invention can also be part of combination therapy [0150].
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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