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 .
DETAILED ACTION
Election of Species and Status of the Claims
Applicant’s election of ‘SAR100842’ as the single LPA Modulator and ‘reduced GLP-1 secretion’ as the single disease/disorder/condition in the response filed on October 23rd 2025 is acknowledged. Claims 1-2, 5-10, 14-15, 21-24, 26, 28, 32, 34, 37, and 44 are pending and are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on May 30th 2023 and April 17th 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Minor Informalities
The list of conditions in claims 28 and 44 recite “metal health.” For the purpose of examination, this phrase will be treated as “mental health.” 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 14, 15, 28, 37, and 44 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.
Claim 14 is indefinite for the phrase “wherein the subject is expected of having a disease or condition…” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim from the claim language. By its nature, the suspicion that a subject has a particular disease/disorder is subjective. Furthermore, applicant provides no guidance in the specification as to how to determine if a subject is suspected of having one of the described diseases/conditions. As one of ordinary skill in the art could not reasonably determine the full scope of the patient population described by claim 14, the claim is indefinite.
Claim 15 is indefinite for the phrase, “wherein modulating glucagon-like peptide 1 (GLP-1) in the subject comprises increasing GLP-1 by: increasing GLP-1 secretion,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 14. Specifically, the claim language does not appear to further limit the LPA inhibitor administered, the subject receiving the inhibitor, the method of administration, the amount administered, or any other aspect of the method. Instead, the phrase appears only to limit the results of the method (i.e. the increase of GLP-1 secretion). This language is repeated in the specification (specification, pg. 11, 13), but guidance as to how the method of claim 14 is further limited by this phrase is not found in the specification. As one of ordinary skill in the art could not reasonably determine how claim 15 further limits the method of claim 14, claim 15 is indefinite.
Claim 28 is indefinite for reciting the conditions, “a serious renal event,” and “mental health,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim from the described conditions. Regarding the term, ‘mental health,’ while applicant briefly describes the effect of GLP-1 on many CNS and PNS disorders (specification, pg. 9), the term ‘mental health’ is never defined in the specification and is, at best, an overly broad categorization that includes any and all central nervous system disorders, peripheral nervous system disorders, psychological disorders, and even day-to-day subjective feelings of the individual. As one of ordinary skill in the art could not reasonably determine the metes and bounds of the term, ‘mental health,’ the term is indefinite.
Similarly, the term, ‘serious renal event,’ is indefinite because one of ordinary skill in the art could not reasonably determine the full metes and bounds of the related patient population. The specification mentions serious renal events (specification, pg. 9), but does not give any indication as to how the relative term, “serious,” limits the described renal events. Based on the description given, one of ordinary skill in the art could conclude that the term includes renal fibrosis, but would not be able to determine the full scope of kidney-related disorders encompassed by the term “serious renal events.” The term is thereby indefinite.
Claim 37 is indefinite for the phrase “by assessing GLP-1 levels or activity in the subject and, if the GLP-1 levels, secretion, or activity is lower than desired…” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 26. Specifically, there is no guidance provided on what constitutes a “desired” GLP-1 level, secretion, or activity. This guidance is provided nowhere in the specification, and only merely the claim language is repeated (specification, pg. 15). One of ordinary skill in the art therefore would have no reasonable expectation of success in determining a “desired” GLP-1 level, secretion, or activity, and claim 37 is indefinite.
Claim 37 recites the limitation "if the GLP-1 secretion is lower than desired, selecting the subject for treatment" in reference to the earlier portion of the claim wherein GLP-1 “levels or activity” are assessed in the subject. As GLP-1 secretion is not assessed, there is insufficient antecedent basis for this limitation in the claim.
Claim 44 is indefinite for the phrase “wherein the subject is expected of having a disease or condition…” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim from the claim language. By its nature, the suspicion that a subject has a particular disease/disorder is subjective. Furthermore, applicant provides no guidance in the specification as to how to determine if a subject is suspected of having one of the described diseases/conditions. As one of ordinary skill in the art could not reasonably determine the full scope of the patient population described by claim 44, the claim is indefinite.
Claim 44 is indefinite for reciting the conditions, “a serious renal event,” and “mental health,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of the claim from the described conditions. Regarding the term, ‘mental health,’ while applicant briefly describes the effect of GLP-1 on many CNS and PNS disorders (specification, pg. 9), the term ‘mental health’ is never defined in the specification and is, at best, an overly broad categorization that includes any and all central nervous system disorders, peripheral nervous system disorders, psychological disorders, and even day-to-day subjective feelings of the individual. As one of ordinary skill in the art could not reasonably determine the metes and bounds of the term, ‘mental health,’ the term is indefinite.
Similarly, the term, ‘serious renal event,’ is indefinite because one of ordinary skill in the art could not reasonably determine the full metes and bounds of the related patient population. The specification mentions serious renal events (specification, pg. 9), but does not give any indication as to how the relative term, “serious,” limits the described renal events. Based on the description given, one of ordinary skill in the art could conclude that the term includes renal fibrosis, but would not be able to determine the full scope of kidney-related disorders encompassed by the term “serious renal events.” The term is thereby indefinite.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 37 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. 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. The assessment of GLP-1 secretion is not found anywhere in the disclosure and is considered to be new matter.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 and 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a method of modulating GLP-1 comprising contacting a cell with an LPA modulator. This judicial exception is not integrated into a practical application because only the contact of the cell with the LPA modulator (a natural phenomenon) and the results of the contact (i.e. the modulation of GLP-1) are recited. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the contact of the cell with the compound and the results of said contact are recited. Claims 2 and 5 further limit the LPA modulator, and claims 6-8 further limit the identity of the cell being contacted with the compound. However, in none of the described claims is more than the contacting of the cell with the compound and the results of said contact recited.
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, 2, 5, 6, 8-10, 22-24, 26, 28, 32, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allanore (Allanore et al., (2018), Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol, 70: 1634-1643).
Claims 1, 2, and 5 are directed towards the contact of a cell with the lysophosphatidic acid receptor (LPAR) antagonist, SAR100842. Allanore teaches oral administration of SAR100842 to humans (Allanore, pg. 1635). Such administration necessarily results in the contact of cells with the compound. As any results of the method (i.e. the modulation of GLP-1 in the cells contacted) would be inherent in the administration of the compound, Allanore thereby anticipates claims 1, 2, and 5.
Claim 6 limits the cells contacted in the method of claim 2 to l-cells, a specialized type of enteroendocrine cell that line the gastrointestinal tract. As Allanore teaches oral administration of SAR100842 (Allanore, pg. 1635), Allanore’s method would necessarily result in the contact of the compound with l-cells, and claim 6 is anticipated by Allanore.
Claim 8 limits the contacting of claim 2 to take place in vivo. As Allanore teaches administration to a human (Allanore, pg. 1635), Allanore anticipates claim 8.
Claims 9-10 are directed towards a method of modulating GLP-1 in a subject comprising administration of SAR100842. As Allanore teaches oral administration of SAR100842 to a human (Allanore, pg. 1635), and any results of the method (i.e. the modulation of GLP-1 subject) would be inherent in the administration of the compound, Allanore thereby anticipates claims 9-10.
Claim 22 is directed towards the treatment or prevention of a disease characterized by reduced GLP-1 levels, secretion, or activity in a subject comprising administration of an inhibitor of LPA. As Allanore meets the limitations of applicant’s recited patient population of “a subject,” Allanore anticipates claim 22. See MPEP 2111.02(II):
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification."
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.)
Claims 23 and 24 limit the LPA inhibitor used in claim 22 to one that antagonizes LPAR-1. As Allanore teaches administration of SAR100842 (Allanore, pg. 1635), and SAR100842 selectively inhibits LPAR-1 (Allanore, pg. 1635, col. 1, last paragraph), Allanore anticipates claims 23 and 24.
Claim 26 limits the LPAR antagonist of claim 23 to SAR100842 and is thereby anticipated by Allanore, who teaches administration of SAR100842 (Allanore, pg. 1635).
Claims 28 and 32 limit the condition treated or prevented in the method of claim 26. As Allanore meets the limitations of applicant’s recited patient population of “a subject,” any effects resulting from administration of the LPA inhibitor (i.e. the prevention or treatment of a disease or the reduction of GLP-1 secretion from L-cells) would be inherent in the administration of the compound, and Allanore thereby anticipates claim 28.
As it is unclear how claim 37 further limits the method of claim 26, Allanore likewise anticipates claim 37.
Claims 1-2, 6, 8-10, 14-15, 21, 22-24, 26, 28, 32, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swaney (Swaney et al., (2010), A novel, orally active LPA1 receptor antagonist inhibits lung fibrosis in the mouse bleomycin model. British Journal of Pharmacology, 160: 1699-1713).
Claims 1 and 2 are directed towards the contact of a cell with the lysophosphatidic acid receptor (LPAR) antagonist, AM966. Swaney teaches oral administration of AM966 (Swaney, pg. 1699, Background and Purpose). Such administration necessarily results in the contact of cells with the compound. As any results of the method (i.e. the modulation of GLP-1 in the cells contacted) would be inherent in the administration of the compound, Swaney thereby anticipates claims 1, and 2.
Claim 6 limits the cells contacted in the method of claim 2 to l-cells, a specialized type of enteroendocrine cell that line the gastrointestinal tract. As Swaney teaches oral administration of AM966 (Swaney, pg. 1699), Swaney’s method would necessarily result in the contact of the compound with l-cells, and claim 6 is anticipated by Swaney.
Claim 8 limits the contacting of claim 2 to take place in vivo. As Swaney teaches administration to mice (Swaney, pg. 1706-1707), Swaney anticipates claim 8.
Claims 9-10 are directed towards a method of modulating GLP-1 in a subject comprising administration of AM966. As Swaney teaches oral administration of AM966 to mice (Swaney, pg. 1706-1707), and any results of the method (i.e. the modulation of GLP-1 subject) would be inherent in the administration of the compound, Swaney thereby anticipates claims 9-10.
Claims 14 and 21 require that, in the method of claim 10, the subject has, or is suspected of having a condition characterized by reduced GLP-1 secretion. One such condition described by applicant is pulmonary fibrosis. Swaney teaches the treatment of pulmonary fibrosis in mice via administration of AM966 (Swaney, pg. 1707, Figure 6), and therefore anticipates claims 14 and 21.
As it is unclear how claim 15 further limits the method of claim 14 (see the above 112(b) rejection for claim 15), claim 15 is similarly anticipated by Swaney.
Claim 22 is directed towards a method of treating or preventing a disease or condition characterized by reduced GLP-1 levels, secretion, or activity in a subject, comprising administration of an LPA inhibitor. One such condition is pulmonary fibrosis. Swaney teaches the treatment of pulmonary fibrosis in mice via administration of the LPA inhibitor, AM966 (Swaney, pg. 1707, Figure 6), and therefore anticipates claim 22.
Claims 23 and 24 limit the LPA inhibitor used in claim 22 to one that antagonizes LPAR-1. As Swaney teaches administration of AM966 (Swaney, pg. 1707, Figure 6), and AM966 selectively inhibits LPAR-1 (Swaney, pg. 1700, col. 1, last paragraph), Claims 23 and 24 are anticipated by Swaney.
Claim 26 limits the LPAR antagonist of claim 23 to AM966, and is anticipated by Swaney, who teaches administration of AM966 (Swaney, pg. 1707, Figure 6).
Claim 28 limits the disease treated in the method of claim 26 to pulmonary fibrosis and is anticipated by Swaney, who teaches the treatment of pulmonary fibrosis (Swaney, pg. 1707, Figure 6).
Claim 32 is directed towards a method of treating or preventing a disease or condition characterized by reduced GLP-1 levels, secretion, or activity in a subject, comprising administration of an LPA inhibitor. One such condition described by applicant is pulmonary fibrosis. Swaney teaches the treatment of pulmonary fibrosis in mice via administration of the LPA inhibitor, AM966 (Swaney, pg. 1707, Figure 6), and therefore anticipates claim 32.
As it is unclear how claim 37 further limits the method of claim 26, Swaney likewise anticipates claim 37.
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.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Swaney in view of Smelcerovic (Smelcerovic et al., DPP-4 Inhibitors in the Prevention/Treatment of Pulmonary Fibrosis, Heart and Kidney Injury Caused by COVID-19-A Therapeutic Approach of Choice in Type 2 Diabetic Patients? Front Pharmacol. 2020 Aug 5; 11:1185).
Claim 34 further limits the method of claim 26 to further comprise administration of a DPP4 inhibitor. For the teachings of Swaney as they relate to claim 26, see the above 102 rejection for claim 26. Swaney teaches the treatment of pulmonary fibrosis via administration of AM966 (Swaney, pg. 1707, Figure 6). Smelcerovic teaches the prevention/treatment of pulmonary fibrosis via administration of a DPP-4 inhibitor (Smelcerovic, pg. 2). One of ordinary skill in the art would therefore find the treatment of pulmonary fibrosis with the combination of AM966 and a DPP-4 inhibitor, prima facie obvious. See MPEP 2144.06(I):
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Claim 34 is thereby prima facie obvious.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Allanore in view of Soare (Soare et al., Dipeptidylpeptidase 4 as a Marker of Activated Fibroblasts and a Potential Target for the Treatment of Fibrosis in Systemic Sclerosis. Arthritis Rheumatol. 2020 Jan;72(1):137-149).
Claim 34 further limits the method of claim 26 to further comprise administration of a DPP4 inhibitor. For the teachings of Allanore as they relate to claim 26, see the above 102 rejection for claim 26. Allanore teaches the treatment of systemic sclerosis via administration of SAR100842 (Allanore, pg. 1635). Soare teaches the treatment of systemic sclerosis via administration of a DPP-4 inhibitor (Soare, pg. 137). One of ordinary skill in the art would therefore find the treatment of pulmonary fibrosis with the combination of Soare and a DPP-4 inhibitor, prima facie obvious. See MPEP 2144.06(I) (quoted above). Claim 34 is thereby prima facie obvious.
Claims 14, 15, 21 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Allanore in view of Khanna (Khanna et al., Etiology, Risk Factors, and Biomarkers in Systemic Sclerosis with Interstitial Lung Disease, 2019 Am J Respir Crit Care Med Vol. 201 Issue 6 pg. 650-660). Claim 44 requires that, in the method of claim 37, the subject has or is suspected of having a condition selected from a list including pulmonary fibrosis.
Claims 14 and 21 require that, in the method of claim 10, the subject has, or is suspected of having a condition characterized by reduced GLP-1 secretion. One such condition described by applicant is pulmonary fibrosis. For the teachings of Allanore as they relate to claim 10, see the above 102 rejection for claim 10. Regarding claim 14, Allanore teaches the treatment of subjects with systemic sclerosis (Allanore, pg. 1635). Khanna teaches that lung (pulmonary) fibrosis occurs in approximately 80% of systemic sclerosis patients (Khanna, pg. 650, Abstract). One of ordinary skill in the art would therefore reasonably “suspect the subject with systemic sclerosis to have pulmonary fibrosis,” and the method of claims 14 and 21 is thereby prima facie obvious.
As it is unclear how claim 15 further limits the method of claim 14 (see the above 112(b) rejection for claim 15), claim 15 is prima facie obvious for the same reasons as claim 14.
For the teachings of Allanore as they relate to claim 37 see the above 102 rejection for claim 37. Regarding claim 44, Allanore teaches the treatment of subjects with systemic sclerosis (Allanore, pg. 1635). Khanna teaches that lung (pulmonary) fibrosis occurs in approximately 80% of systemic sclerosis patients (Khanna, pg. 650, Abstract). One of ordinary skill in the art would therefore reasonably “suspect the subject with systemic sclerosis to have pulmonary fibrosis,” and the method of claim 44 is thereby prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629