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 preliminary amendments of 25 March 2022, 16 December 2022, and 26 June 2025 have been entered in full. Claims 1-130 are canceled. Claims 131-153 are under examination.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 135 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 135 recites the limitation “…administered before or after the onset of one or more symptoms…” which encompasses administration at any time point. Accordingly, claim 135 fails to further limit claim 131. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 143 is 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.
Claim 143 recites the limitation "the ocular inflammatory disease" in line 2. There is insufficient antecedent basis for this limitation in the claim, or in claims 131 and 141, from which claim 143 ultimately depends.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 131-137 and 140-153 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheung et al. (US 2016/0032009 A1; published 04 February 2016) in view of WO 2016/022883 A1 (MEMORIAL SLOAN-KETTERING CANCER CENTER AND DERAMIDE THERAPEUTICS; published 11 February 2016; hereinafter ‘883) and Barber et al. (2011, Investigative Ophthalmology & Visual Science 52:1156-1163).
Cheung et al. teach a method of treating or preventing diabetic retinopathy in a subject in need thereof comprising administering an anti-ceramide antibody or antigen-binding fragment thereof to the subject. See abstract, [0317]. Note that GD2 is a type of ceramide. See Figure 2, [0051]. This is relevant to claim 131.
Regarding claim 133, scFv forms of the antibody are taught at [0009].
Regarding claim 134, single dose administration is taught at [0107] “one or more doses.”
Regarding claim 135, the limitation of “administered before or after the onset of one or more symptoms” includes administration at any time. Since claim 135 fails to further limit claims 131 (see discussion under 35 U.S.C. 112(d) above), no further disclosure by the reference is required to be identified.
Regarding claim 140, insofar as Cheung et al. teach prevention, such is understood to encompass delaying the onset of symptoms. See [0136].
Regarding claim 141, Cheung et al. teach treatment, which is understood to encompass reduction of symptoms. See [0148].
Cheung et al. do not explicitly teach administration of an anti-ceramide antibody having the CDR sequences recited in the claims, such as SEQ ID NOs: 1, 44, 3, 4, 5, and 6 (comprised in antibody 6B5), SEQ ID NOs: 49 and 50 (comprised in antibody 6B5), SEQ ID NOs: 33-38 (comprised in antibody 2A2), or SEQ ID NOs: 1-6 (antibody 6B5).
However, ‘883 teaches these antibodies and methods of administering the antibody to inhibit apoptosis. See abstract, [0049], [0050], [0057]. Barber et al. explain that diabetic retinopathy is associated with apoptosis of neural and vascular cell sin the retina (see abstract).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the method of administering an anti-ceramide antibody to treat/prevent diabetic retinopathy as taught by Cheung et al. by using the antibodies of ‘883. A reasonable expectation of success and motivation to make the modification can be found in Barber et al., who discuss the debilitating effects of diabetic retinopathy as well as the involvement of apoptosis in the progression of the disease.
Furthermore, Cheung et al. do not explicitly recite the effects of the administration as per instant claims 142-151. However, insofar as the combined teachings of the references suggest administering the same therapeutic agents to the same patient population, such effects would necessarily have occurred by practicing the method. In the absence of evidence of unexpected results, these effects are also rendered obvious by the combined teachings of the cited references.
Claim(s) 138 and 139 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheung et al. (US 2016/0032009 A1; published 04 February 2016) in view of WO 2016/022883 A1 (MEMORIAL SLOAN-KETTERING CANCER CENTER AND DERAMIDE THERAPEUTICS; published 11 February 2016; hereinafter ‘883) and Barber et al. (2011, Investigative Ophthalmology & Visual Science 52:1156-1163) as applied to claims 131-137 and 140-154 above, and further in view of Scott et al. (US 2003/0180265 A1; published 25 September 2003).
As discussed above, Cheung et al. in view of ‘883 and Barber et al. teach a method of treating or preventing diabetic retinopathy in a subject in need thereof comprising administering an anti-ceramide antibody or antigen-binding fragment thereof to the subject, wherein the antibody or antigen-binding fragment thereof has the sequences recited in the instant claims.
Cheung et al. do not explicitly teach intraocular or intravitreal administration.
However, it was known that diabetic retinopathy involves damage to the retina, only access through the eye. It was also known that administration of antibodies to treat diabetic retinopathy were routinely administered intravitreally in order to have the antibody reach the target tissue. See Scott et al., [0009], for example.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the method of administering an anti-ceramide antibody to treat/prevent diabetic retinopathy as taught by Cheung et al. by using the antibodies of ‘883. It would have been further obvious to modify the method by administering the antibody intravitreally in view of the teachings of Scott et al. that other antibodies are administered intravitreally to treat diabetic retinopathy. A reasonable expectation of success and motivation to make the modification can be found in Barber et al., who discuss the debilitating effects of diabetic retinopathy as well as the involvement of apoptosis in the progression of the disease. Further reasonable expectation of success and motivation are provided by Scott et al., who teach that administration of an antibody to treat diabetic retinopathy can be effectively achieved using intravitreal administration routes.
Double Patenting
Statutory:
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 152 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 10,975,169 B1. This is a statutory double patenting rejection.
Non-Statutory:
The nonstatutory double 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 nonstatutory double patenting 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 in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting 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 terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer 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 terminal disclaimer 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 may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 131-151 and 153 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,975,169 B1 in view of WO 2016/022883 A1 (MEMORIAL SLOAN-KETTERING CANCER CENTER AND DERAMIDE THERAPEUTICS; published 11 February 2016; hereinafter ‘883) and Barber et al. (2011, Investigative Ophthalmology & Visual Science 52:1156-1163). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Both sets of claims are directed to methods of administering anti-ceramide antibodies for the treatment/prevention of diabetic retinopathy, with the same types of administration methods and effects.
The difference between the claim sets is that the instant claim set recites antibody sequences pertaining to antibody 6B5 whereas the patented claims recite sequences pertaining to antibody 2A2. However, ‘883 discloses both antibodies and their sequences, and indicates that either can be administered to treat diseases characterized by apoptosis. See abstract, [0049], [0050], [0057]. Barber et al. explain that diabetic retinopathy is associated with apoptosis of neural and vascular cell sin the retina (see abstract).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH C. KEMMERER whose telephone number is (571)272-0874. The examiner can normally be reached M-F 6:30-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELIZABETH C. KEMMERER/Primary Examiner, Art Unit 1674
/ECK/
02 August 2025
Prosecution Insights