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 11/5/25 has been entered in full. Claims 4-6, 12-14 and 18-20 are canceled. Claims 1-3, 8, 10-11 and 15-17 are amended. Claims 1-3, 7-11 and 15-17 are pending.
Sequence Compliance
Applicants’ response filed on 1/27/26 to the Notice to Comply with the requirements for sequences has been considered and is found sufficient to comply.
Election/Restrictions
Applicants' election without traverse of Group I, claims 1-3, 7-11 and 15-17, in the reply filed on 11/5/25 is acknowledged. The pending claims as amended are now limited to the subject matter of Group I.
The elections of (1) liver fibrosis as the species of type of treatment, and (2) hLept-3 as the species of antibodies, in the reply filed on 11/5/25 are also acknowledged. Claims 8-11 and 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of type of treatment, there being no allowable generic or linking claim.
Claims 1-3 and 7 are under consideration, as they read upon the elected species.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because (1) in part it is directed to “Therapeutic Agents” which are (a) products, but the claim is limited to methods; and (b) broadly encompass any form of therapeutic agents, where as the claims are limited to using therapeutic agents that are anti-leptin antibodies; and (2) in part it is directed to “Uses Thereof”, which broadly encompasses any type of use but the claims are limited to treatment uses. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Methods of Treatment with Anti-Leptin Antibodies”.
Appropriate correction is required.
Claim Objections
Claims 1-3 and 7 are objected to because of the following informalities:
In claim 1, line 1, “treating liver disease, liver fibrosis, liver cirrhosis” should be “treating liver disease, treating liver fibrosis, treating liver cirrhosis” because each of the subsequent conditions also include the word treating; e.g., “treating cancer…”
In claim 1, line 4, the acronym “GLP-1” should be accompanied by the full terminology; e.g., “glucagon-like peptide 1 (GLP-1)”.
In claim 1, line 7, the acronym “PD-1” should be accompanied by the full terminology; e.g., “programmed death 1 (PD-1)”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-3 and 7 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 pre-AIA the applicant regards as the invention.
In claim 1, lines 1-9, the Markush-type group of conditions recited is joined by the conjunction “and” (i.e., “….and combinations thereof”), which makes it unclear whether one or each of the recited conditions are being treated in the subject. In this regard, the claim can be rendered definite by either amending the conjunction to “or”, or by amending the claim to recite that the condition is selected from the group; e.g., “…a method of treating a condition selected from the group consisting of liver disease… and combinations thereof.”
In claim 1, line 3, the phrase “treating or cardiovascular disease” is missing one or more words, rendering the meaning unclear.
In claim 1, line 5, “increasing insulin sensitivity within 24 or fewer hours” is indefinite because it does not indicate what the “within 24 or fewer hours” is with respect to; i.e., increasing insulin sensitivity within 24 or fewer hours of what event.
In claim 1, lines 9-11, now recites, ““…comprising administering a therapeutic agent for lowering circulating leptin to a subject in need the thereof, an anti-leptin antibody or specific fragment thereof.” This language is indefinite because the deletion of the words “wherein the therapeutic agent is” renders the claim indefinite because it removes the joining words that identify the antibody of claim 11 as a narrowing limitation of the therapeutic agent of lines 9-10.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Note on Prior Art Rejection(s)
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.
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.
(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.
Claims 1-2 and 7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ilan et al, U.S. Patent 8,969,291, published 3/3/15 and filed 9/7/10. The earliest date to which the instant application claims priority is 9/21/20.
Claim 1 encompasses a method of treating liver fibrosis (the elected species of type of treatment under consideration) comprising administering a therapeutic agent for lowering circulating leptin to a subject in need thereof, wherein the agent is an anti-leptin antibody.
The ‘291 patent claims a method comprising administering “an antibody specific for leptin” to “decrease the amount … of leptin” in the subject, and wherein the subject has a liver disease selected from a group include hepatic fibrosis; see claim 1. “Hepatic fibrosis” is equivalent to “liver fibrosis” as recited in the instant claims. As such, the teachings of ‘291 anticipate instant claim 1.
Claim 2 encompasses a method of claim 1 wherein the antibody is “hLept-3” (the elected species of antibody under consideration). The term “hLept-3” is not provided with a limiting definition in the specification and instead is only provided with exemplary heavy and light chain variable region CDR sequences (e.g., in Table 1 and 2). Therefore, the term “hLept-3” is interpreted broadly as encompassing any anti-leptin antibody. As such, the teachings of ‘291 that anticipate claim 1 also meet the limitations of claim 2.
Claim 7 encompasses a method of claim 1 wherein an amount of circulating leptin is lowered by 30 to 90% in the subject. This further 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, in claim 7, the claim simply expresses the intended result (a decrease in circulating leptin) of a process step positively recited (administering an anti-leptin antibody). As such, the teachings of ‘291 set forth above for claim 1 also anticipate claims dependent claim 7.
Double Patenting
The nonstatutory double (NSDP) patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A NSDP rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains TD forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,037,390, issued 7/16/24, and which shares the same applicant and inventors with the instant application, and further in view of Ilan et al, U.S. Patent 8,969,291, published 3/3/15.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claim 1 encompasses a method of treating liver fibrosis (the elected species of type of treatment under consideration) comprising administering a therapeutic agent for lowering circulating leptin to a subject in need thereof, wherein the agent is an anti-leptin antibody. Instant claim 2 encompasses a method of claim 1 wherein the anti-leptin antibody is “hLept-3”. Instant claim 3 encompasses a method of claim 1 wherein the anti-leptin antibody has a VH and VL comprise HCDR1-3 and LCDR1-3 of SEQ ID NO: 3, 8, 13, 18, 23 and 28, which are the CDR sequences of the h-Lept-3 antibody as disclosed in the instant application.
Claim 4 of ‘390 is directed to a “method reducing leptin levels in a human subject, comprising administering an effective amount of the antibody of claim 1 to the subject”. The antibody of claim 1 is an “isolated antibody designated hLept3 that binds leptin” and comprises CDRs having the same amino acid sequences as the hLept3 antibody of the instant application. Thus, claim 4 of ‘390 is directed to a method meeting each of the limitations of instant claim 1, except that claim 4 does not include the limitation that the method is for treatment of liver fibrosis in a subject in need thereof.
The ‘291 patent claims a method comprising administering “an antibody specific for leptin” to “decrease the amount … of leptin” in the subject, and wherein the subject has a liver disease selected from a group include hepatic fibrosis; see claim 1. “Hepatic fibrosis” is equivalent to “liver fibrosis” as recited in the instant claims.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of claim 4 of ‘390 as directed to reducing leptin levels in a human subject by administering a hLept3 anti-leptin antibody and modify said method to apply it to a subject having liver fibrosis as taught by ‘291. The person of ordinary skill in the art would have been motivated to make such a change in order to treat liver fibrosis. The person of ordinary skill in the art would have had a reasonable expectation of success because the ‘291 patent teaches that liver fibrosis can be treated with anti-leptin antibodies in general, and ‘390 is directed to such a type of antibody. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007). Such a modified method would meet the limitations of instant claims 1-3 in so far as directed to use of a hLept-3 antibody.
Claim 7 encompasses a method of claim 1 wherein an amount of circulating leptin is lowered by 30 to 90% in the subject. This further 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. Specifically, in claim 7, the claim simply expresses the intended result (a decrease in circulating leptin) of a process step positively recited (administering an anti-leptin antibody). As such, the modified method over the claims of ‘390 in view of the teachings of ‘291 also meets the limitations of claim 7.
Conclusion
No claims are allowable.
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
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