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 .
Status of the Application
The claims of 2 April 2023 are entered.
The election of 18 March 2026 is entered.
Claims 1-20 are pending. Claims 1-7 and 20 are withdrawn without traverse. Claims 8-19 are being examined on the merits.
Election/Restrictions
Applicant’s election of Group II (claims 8-19) in the reply filed on 18 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-7 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 March 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. EP20382876.9 and EP21182899.1, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Neither prior-filed EPO application claims or discloses that boron compounds are combined with an adjuvant comprising fibronectin. No mention of fibronectin is found in either application. As the prior-filed applications cannot support the claimed subject matter in the manner provided for by 35 U.S.C. 112(a), the earliest effective filing date is 4 October 2021, the filing date of the PCT/EP2021/077313 application.
Claim Interpretation
Claim 8 recites within the preamble that the combination is “for use in a method to induce myotube formation, increase myotube diameter and/or suppressed cell mortality in a mammal in need thereof”. This is interpreted as expressing an intended use. MPEP 2111.02 states regarding such statements that:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase "treating a cancer" "’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells."); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase "rich in glucosinolates" helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently "rich in glucosinolates")).
In this instance, the body of the claim fully sets forth all of the limitations of the claimed invention in the form of a boron compound and an adjuvant. Accordingly, the intended use is not considered a limitation of significance to claim construction.
Claims 8 and 10 recite that “…the cell adhesion peptide domain is a peptide which comprises of consists of a sequence selected from a list consisting of…” The broadest reasonable interpretation of “a sequence” includes the full-length peptides as claimed and all fragments contained therein because of the use of the indefinite article. To limit the claim to only the sequences of SEQ ID NOs: 1-7, the Applicants should delete the indefinite article “a” and replace with the definite article “the” therefor.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “from 10 to 10-6”, and the claim also recites “preferably from 5 to 10-6 by weight” which is the narrower statement of the range/limitation. Claim 10 recites the broad recitation “from 10 to 10-6”, and the claim also recites “preferably from 5 to 10-6 by weight” which is the narrower statement of the range/limitation. Claim 13 recites the broad recitation “an injectable composition”, and the claim also recites “preferably an injectable subcutaneous or intramuscular composition” which is the narrower statement of the range/limitation. Claim 15 recites the broad recitation “where the cancer is a cancer derived from the epithelial tissue”, and the claim also recites “even more preferably, the cancer is selected from the list consisting of colon cancer, breast cancer, pancreatic cancer, lung cancer, and ovarian cancer” which is the narrower statement of the range/limitation. Claim 16 recites the broad recitation “the pathophysiological condition which affects skeletal muscle is a dystrophy”, and the claim also recites “preferably, the dystrophy is selected from the list consisting of myotonic dystrophy type 1, myotonic dystrophy type 2 and Duchenne muscular dystrophy” which is the narrower statement of the range/limitation. Claim 18 recites the broad recitation “from 10-6 to 1 mg weekly”, and the claim also recites “preferably, from 1.10-4 to 0.5 mg once or twice weekly or from 1.10-2 to 0.1 mg once or twice weekly” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of prior art, the Examiner interprets each claim as being directed to the broad range.
Claim 16 recites the limitation "wherein the pathophysiological condition which affects skeletal muscle is a dystrophy" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. The claim is linked to claim 13, which does not recite a pathophysiological condition, nor does claim 10 from which claim 13 is dependent. For the purposes of prior art the Examiner interprets the claim as correctly depending from claim 14,
Claims 8, 14-16, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: any actual administration of the composition. Each claim recites that the composition is “for use in a method…”, “for use as…” or “for use in the prevention and/or treatment…”. These are treated as intended uses of the composition, but in no cases are any steps recited that actually administer the composition.
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 (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 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.
1. Claims 8-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by March J and Clark E (US 10,328,116 B2, published 25 June 2019, hereafter referred to as ‘116).
The ‘116 patent claims a combination of a proteasome inhibitor and a cyclic peptide comprising RGD at a ratio of 1:5000 to 1:10 w/v of the proteasome inhibitor to the cyclic peptide (see e.g. claim 1). The proteasome inhibitor can take the form of boronate compound including bortezomib (see e.g. claims 2 and 3). The ‘116 patent further discloses that the ratio between the proteasome inhibitor and the cyclic peptide can be 1:1 (see e.g. Col.11). This anticipates claims 8 and 9, since it combines a boron compound and an adjuvant comprising a cell adhesion peptide comprising SEQ ID NO: 1, and allows for weight ratios of 1:1.
With respect to claim 10, ‘116 claims that the composition can be prepared as a pharmaceutical composition (see e.g. claim 22).
With respect to claim 11, as noted above ‘116 claims and discloses combinations of a cyclic RGD peptide with bortezomib as the boronate compound.
With respect to claim 12, as noted above ‘116 claims a combination of cyclic RGD and bortezomib, and allows for ratios of the bortezomib to RGD of 1:5000 to 1:10 w/w, within the range as claimed.
With respect to claim 13, the compositions of ‘116 are noted to be administered subcutaneously (see e.g. Col.21 lines 6-8).
With respect to claims 14-17 and 19, each claim expresses a use of the combination. The ‘116 composition is capable of each use, since it contains the required boron compound and adjuvant. Boron compounds are suggested for muscular dystrophies as in claims 14, 16, 17, and 19, offering a reasonable expectation that other boron-containing compounds would be capable of use in such a therapy (see e.g. WO 2020/058482 as cited on the IDS of 2 April 2023). Bortezomib is well established as useful in cancer treatment as in claim 15, offering a reasonable expectation that bortezomib-containing compositions would be capable of use in such a therapy (see e.g. ClinicalTrials.gov NCT0052507). With respect to the use of claim 15 see also claim 18 of ‘116.
With respect to claim 18, ‘116 discloses varying doses of bortezomib as needed (see e.g. Col.21-22). ‘116 also discloses doses of 0.2-1 mg/kg for mice, i.e. once weekly, which falls within the range claimed for a single dose.
2. Claims 8-11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (ACS Applied Materials & Interfaces 10:41003-41011, published 7 November 2018, hereafter referred to as Wang.
Wang discloses a G5 PMAM fused to a PEG group, to which is attached cyclic RGD and bortezomib (see e.g. Figure 1). Wang indicates that an average of 2 cRGD are fused to each G5 dendrimer and a molar ratio between the bortezomib and the dendrimer was 10:1. This would fall between the 10-10-6 range as claimed. Wang therefore anticipates claim 8, since the intended use is not considered to be of significance to claim construction, an adjuvant in the form of a peptide comprising RGD is present, and a boron compound in the form of bortezomib is present. The claims only require that a combination be present, which is fulfilled by a conjugated compound, and do not exclude additional elements given the “comprising” transitional phrasing.
With respect to claim 9, the ratio of the bortezomib to cRGD of Wang falls within the range as claimed.
With respect to claim 10, the complex is administered to MDA-MB-231 cells, i.e. a pharmaceutical composition (see e.g. Figure 4).
With respect to claim 11, as noted above Wang discloses bortezomib.
With respect to claim 15, while the claim expresses an intended use, the results of Wang indicate that it can be used in treatment of cancer given the effects on MDA-MB-231 cells.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
