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 .
Election/Restrictions
Applicant’s election without traverse of the species of lysosomal acid lipase replacement therapy in the reply filed on 05/14/2026 is acknowledged.
In light of further search and consideration, the Examiner has rejoined the species of “LAL replacement therapy and PD-L1 inhibitor” with the elected species of “LAL replacement therapy.”
Claim Status
The amendment of 05/14/2026 has been entered. Claims 1-20 are pending in this US patent application. Claims 9-11 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/2026.
Claims 1-8, 12-18, and 20 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 11/14/2025 has been received and considered.
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 1-8, 12-13, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US patent application publication 2019/0076508 filed by Yan et al., published 03/14/2019.
Yan teaches a method for reducing cancer tumor growth in an individual in need thereof, the method comprising administering lysosomal acid lipase (LAL) in combination with a PD-L1 inhibitor to the individual (see entire document, including claims 61-62; reads on instant claims 1, 7, 12, and 18). The cancer may be lung cancer (claim 63; reads on instant claim 20). The LAL therapy suppresses MDSC expansion and, thus, promotes anti-cancer immunity (paragraph 0009; reads on claim 2). The MDSCs express CD11b and are lal-negative (paragraph 0145; reads on claims 3-4). The compositions may be formulated in pharmaceutically acceptable carriers as powders for oral administration or liquids for injection (reads on claims 5-6 and 13). One particularly suitable LAL source is the commercially available drug KANUMA (paragraph 0084; reads on claim 8; the Examiner notes that KANUMA is the brand name of sebelipase alfa as instantly recited).
Therefore, claims 1-8, 12-13, 18, and 20 are anticipated by Yan and are rejected under 35 U.S.C. 102(a)(1).
Claim Rejections - 35 USC § 103
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.
Claims 1-8, 12-13, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2019/0076508 filed by Yan et al., published 03/14/2019.
As discussed above, claims 1-8, 12-13, 18, and 20 are anticipated by Yan. In addition, Yan clearly contemplates administering multiple dosages of treatment compositions (paragraphs 0081-0085). However, Yan does not explicitly teach administering multiple doses of the composition comprising an LAL replacement therapy and a PD-L1 inhibitor.
While Yan does not explicitly teach administering multiple doses of the composition comprising an LAL replacement therapy and a PD-L1 inhibitor, it would have been obvious to one of ordinary skill in the art to do so because Yan clearly contemplates administering multiple dosages of treatment compositions. Administering at least two doses of a treatment composition comprising an LAL replacement therapy and a PD-L1 inhibitor would result in at least one administration of a composition comprising an LAL replacement therapy before a composition comprising a PD-L1 inhibitor and in at least one administration of a composition comprising an LAL replacement therapy after a composition comprising a PD-L1 inhibitor as recited in instant claims 16-17, given that these claims do not preclude the composition and the anti-tumor treatment from being administered together. One of ordinary skill in the art would have a reasonable expectation that administering multiple doses of a treatment composition comprising an LAL replacement therapy and a PD-L1 inhibitor as suggested by Yan would successfully result in the treatment of the cancer in the subject.
Therefore, claims 1-8, 12-13, 16-18, and 20 are rendered obvious by Yan and are rejected under 35 U.S.C. 103.
Claims 1-8, 12-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application publication 2019/0076508 filed by Yan et al., published 03/14/2019, in view of Hsu et al., J. Immunol. Res. 2017: 6940546 (2017).
As discussed above, claims 1-8, 12-13, 16-18, and 20 are rendered obvious by Yan. In addition, Yan teaches that the PD-L1 inhibitors used in the treatment of patients with LAL replacement and PD-L1 inhibitors may be FDA-approved check point inhibitors (paragraph 0367). However, Yan does not teach that these PD-L1 inhibitors are an immunotherapy as recited in instant claims 14-15.
Hsu teaches that three anti-PD-L1 monoclonal antibodies were approved by the FDA for the treatment of cancer from May 2016-May 2017 (see entire document, including page 1, abstract, and page 2, Figure 1; cf. claims 14-15).
While Yan does not teach that the PD-L1 inhibitors in the LAL replacement/PD-L1 inhibitor treatment are an immunotherapy as recited in instant claims 14-15, it would have been obvious to one of ordinary skill in the art to include immunotherapeutic PD-L1 inhibitors in the compositions of Yan because Yan teaches that the PD-L1 inhibitor can be an FDA-approved PD-L1 inhibitor and because Hsu teaches three immunotherapeutic drugs that are FDA-approved PD-L1 inhibitors. One of ordinary skill in the art would have a reasonable expectation that using the anti-PD-L1 monoclonal antibodies of Hsu as the FDA-approved PD-L1 inhibitors suggested by Yan in Yan’s method of treating cancer with an LAL replacement therapy and a PD-L1 inhibitor would successfully result in the inhibition of PD-L1 in the patient.
Therefore, claims 1-8, 12-18, and 20 are rendered obvious by Yan in view of Hsu and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
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 1, 7, 12, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-15 of U.S. Patent No. 10857209. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of ‘209 are narrower than the instant claims. As such, the cited instant claims are ‘anticipated by’ the cited claims of ‘209 and are rejected on the ground of nonstatutory double patenting.
Claims 1, 7, 12, 14-15, 18, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-15 of U.S. Patent No. 10857209 in view of Hsu et al., J. Immunol. Res. 2017: 6940546 (2017).
As discussed above, claims 1, 7, 12, 18, and 20 are ‘anticipated by’ the cited claims of ‘209. The additional limitations of instant claims 14-15 would be rendered obvious by the portions of Hsu cited above under Claim Rejections – 35 USC 103 for the same reasons as cited above. As such, claims 1, 7, 12, 14-15, 18, and 20 are ‘rendered obvious’ by the cited claims of ‘209 in view of Hsu and are rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/17/2026
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