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 .
Priority
The instant application, filed 09/03/2024, is the national stage entry of PCT/EP2023/055490, filed 03/03/2023, which claims priority to an application filed in the Europe, EP22160079.4, filed on 03/03/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55.
Information Disclosure Statement
The three Information Disclosure Statements received, one each on 09/06/2024, 04/29/2026, and 07/01/2026, are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the Information Disclosure Statements have been considered.
Status of Claims
Claims 1-9 were originally presented on 09/03/2024. The preliminary amendments to the claims, also received on 09/03/2024, are acknowledged and entered. Claims 1-8 were amended, claim 9 was maintained as originally presented, and claims 10-12 were added.
Accordingly, claims 1-12 are pending.
Claim Objections
Claim 2 objected to because of the following informalities:
Claim 2 is unclear primarily due to the fact that the specification fails to provide chemical structures for any of the actives. This results in a direct problem with the third compound recited in claim 2, named “7-(3-(N-(4-trifluoromethyl-2,6-dimethyl-phenyl)sulfamoyl)phenyl)heptanoic acid”. This exact chemical name appears once in the Specification at 6, line 15, wherein it describes it as a “preferred” embodiment of a GRP120 agonist of formula (I). Another chemical that appears to be identical is named in the Specification at 14, “7-(3-(N-(2,6-dimethyl-4-(trifluoromethyl)phenyl)sulfamoyl)phenyl)heptanoic acid”, which is designated DFL23922.
Both names result in the following structure.
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The use of different names for the same compound in the Specification and the claims leads to the impression that the compounds are somehow different. This makes interpreting the claims unnecessarily difficult, and reasonably could have raised a 112(b) rejection. Further, this issue may occur with other compounds named in the specification, because optical character recognition errors in chemical names often results in text searches not finding compounds.
To avoid the confusion regarding which actives are recited in claim 2, Applicant is required to provide the chemical structures of the recited actives in response to this objection, and pending further amendments to the claims, consider adding the chemical structures of the actives recited directly within claim 2.
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 11 and 12 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.
Claims 1, 11 and 12, taken from the PG-PUB to preserve formatting, US Patent Application Publication No. 2025/0177329 A1, are annotated below. It is unclear which “phenyl” is the “said phenyl” recited in claims 11 and 12 because there are multiple phenyls, any of which could be “said phenyl”. As a result, it is unclear which species are encompassed by claims 11 and 12.
See annotated claims 1, 11 and 12:
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Annotated claims 1, 11 and 12.
Now see, claim 11, which recites, “when said phenyl … is substituted, the substituent is selected from Cl, F, and CH3”, and consider the actives disclosed in the specification, DFL23916 and DFL23917. These are the only disclosed compounds that have an R1 or R2 variable as phenyl.
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DFL23916 (fourth compound claim 2)
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DFL23917 (sixth compound of claim 2)
In each case, R1 or R2 is phenyl, the R1 or R2 is substituted with another phenyl, and that phenyl in is substituted with F in the same position, which is R3 of formula (I), and is at the 4 position of that other phenyl. It is unclear if that alone means that DFL23916 and DFL23917 are embodiments of claims 11 and 12, or if Applicant intends the claim to instead only encompass compounds wherein the R1 or R2 variable itself is substituted by something other than phenyl. The latter interpretation would then encompass compounds that are not disclosed in the specification and raise an enablement issue regarding how to administer undisclosed actives for preventing or treating inflammatory bowel disease.
Accordingly, claims 11 and 12 are rejected as indefinite, as it is unclear which species are encompassed by the claims.
The examiner will interpret the actives DFL23916 and DFL23917 as embodiments of claims 11 and 12, in view of the preceding discussion.
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 1-12 Anticipated by US’090
Claim(s) 1-12 is/are rejected under both 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US’090.1
The claims are drawn to pharmaceutical compositions comprising GRP120 agonists of formula (I), and the intended use of such compositions in medicinal methods for treating inflammatory bowel disease. See formula (I) from the instant claim 1:
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.
The active designated DFL24102 is an embodiment of instant claims 1-2 and 4-12. Its chemical name is 7-(3-{[4-fluoro-2-methyl-5-(thiophen-2-yl)phenyl]sulfamoyl}phenyl)heptanoic acid. It is named specifically in claims 2 (fifth compound) and 9, has a CAS Reg. No. of 2978424-61-0, and is represented by the following chemical structure:
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DFL24102
DFL24102 appears to be newly disclosed by the filing of the foreign priority application, EP22160079.4.
However, in US’090, Applicant patented another active designated DFL23914, which is an embodiment of instant claims 1-8. Its chemical name is 7-(3-(N-(4-chloro-2,6-dimethylphenyl)sulfamoyl)phenyl)heptanoic acid. It is specifically named in instant claims 2 (second compound), and 3, has a CAS Reg. No. of 2185867-20-1, and is represented by the following chemical structure:
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DFL23914
See, e.g., US’090 at col. 33, claim 1 (general Markush structure), cols. 34 and 36, claims 8-9 (dependent on claim 1, and both reciting as the fourth compound “7-(3-(N-(4-chloro-2,6-dimethylphenyl)sulfamoyl)phenyl)heptanoic acid”, which is DFL23914).
See also, US’090 at cols. 11-12, Example 4 (providing its synthesis and designating it compound 4), col. 23, Table 1, providing its chemical structure and hGPR120 activity, and col. 24 (stating it was one of the “most active” compounds discovered having “significant agonistic activity on GPR120 and GPR40…”.
Claim 10 teaches its medicinal use in a method for treating a disease or disorder modulated by GPR120, comprising administering DFL23914, alone or in combination with one or more pharmaceutically acceptable excipients.
Claim 11 recites some specific indications for DFL23914 that either directly encompass inflammatory bowel disease, or are so close in nature that a reasonable person of skill in the art would interpret the administration of DFL23914 as being effective for treating inflammation in the bowels.
See, e.g., US’090 at claims 10 and 11:
10. A method for the treatment of a disease or disorder modulated by GPR120 and/or GPR40 in a subject in need thereof, comprising administration of an effective amount of the compound according to claim 1, alone or in combination with one or more pharmaceutically acceptable excipients.
11. The method according to claim 10, wherein the disease or disorder is selected from the group consisting of diabetes, type 2 diabetes, impaired oral glucose tolerance, insulin resistance, obesity, obesity related disorders, metabolic syndrome, dyslipidemia, elevated LDL, elevated triglycerides, obesity induced inflammation, osteoporosis and obesity related cardiovascular disorders.
US’090 at claims 10 and 11.
Reading US’090 alone makes it quite clear that it was well-known that GPR120 agonists, when administered, suppressed inflammation in the bowels.
For example, one of skill in the art, reading US’090, would learn that it was well-known that GPR120 was highly expressed in the bowels.
See, e.g., US’090 at col. 1:
GPR120 is highly expressed in the intestine (enteroendocrine L cell of the colon and cell lines such as STC-1), but also in the lung, thymus, spleen, and pancreas [Hirasawa A. et al., Nat Med (2005), 11(1): p. 90-4; Taneera J. et al., Cell Metab (2012), 16(1): p. 122-34; Tanaka T. et al., Naunyn Schmiedebergs Arch Pharmacol (2008), 377(4-6): p. 523-7].
US’090 at col. 1.
One of skill in the art, reading US’090, would learn that it was well-known that administration of GPR120 agonists, which include omega-3 fatty acids, block “inflammatory cytokine release”, and that such studies were even documented in the prestigious Nature journals wherein it was shown mechanistically in a validated model that the administration of a novel small molecule GPR120 agonist “demonstrated the potent anti-inflammatory effects of GPR120 activation”. See, e.g., US’090 at col. 2.
Finally, it has been shown that GPR120 on macrophages can be activated by omega-3 fatty acids for the repression of inflammatory cytokine release. GPR120 anti-inflammatory effects are mediated by β-arrestin signalling [Oh D. Y. et al., Cell (2010), 142: p 687-98]. In vivo experiments on obese mice treated with an orally available GPR120 agonist, demonstrated the potent anti-inflammatory effects of GPR120 activation and the consequent improved glucose tolerance, decreased hyperinsulinemia, increased insulin sensitivity and decreased hepatic steatosis [Oh D. Y. et al., Nat Med (2014), 20: p 942-7].
US’090 at col. 2.
See also, US’090 at page 2, right column, wherein it provides the title to the 2014 Nature Medicine publication referenced in the above passage, that explicitly states GPR120-selective agonism improves chronic inflammation.
Moreover, the instant Specification itself admits that it was well-known that omega-3 fatty acids have been used for treating IBD. See, e.g., instant Specification 2, paragraph with the citation to Marton et al, International Journal of Molecular Science 2019, 20 (19), 4851.
In view of the well-known background reported in US’090 regarding administration of GPR120 agonists for treating inflammation, one of skill in the art would at once envisage a method for preventing or treating inflammatory bowel disease in an individual, the method comprising administering to the individual DFL23914 alone or in combination with one or more pharmaceutically acceptable excipients. One of skill in the art would at once envisage the additional indication for the treatment – the method for preventing or treating inflammatory bowel disease, wherein the inflammatory bowel disease is ulcerative colitis or Crohn's disease, because treating inflammation in the bowels would provide a therapeutic benefit to such patients.
One of skill in the art would at once envisage administering to the individual DFL23914 in an orally administered pharmaceutical composition that is not a controlled release formulation and/or gastro-resistant formulation, but could contain an inert pharmaceutically acceptable excipient, because the inventors of US’090 discovered that DFL23914 could be administered as syrups or pills for the treatment of a disease or disorder modulated by GPR120, which includes chronic inflammation in the bowels, without the need of any controlled release formulation and/or gastro-resistant formulation. See, e.g., US’090 at col. 36, claims 12-15 (even an enema works).
Accordingly, claims 1-8 are anticipated by US’090.
Regarding claims 11-12, as discussed in the section regarding 112(b), the specification discloses the active designated DFL23917, which is named “7-(3-(N-(5-fluoro-3-methyl-[1,1′-biphenyl]-2-yl)sulfamoyl)phenyl)heptanoic acid”. It is named specifically in claim 2 (sixth compound), has a CAS No. of 2185867-26-7, and is represented by the following chemical structure:
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DFL23917
However, the inventors of US’090 already patented this compound. See US’090 at col. 33, claim 1 (general Markush structure), cols. 34 and 36, claims 8-9 (dependent on claim 1, and respectively reciting as the tenth and eight compound “7-(3-(N-(5-fluoro-3-methyl-[1,1′-biphenyl]-2-yl)sulfamoyl)phenyl)heptanoic acid”, which is DFL23917).
See also, US’090 at col. 14, Example 10 (providing its synthesis and designating it compound 10), col. 25, Table 1, providing its chemical structure and hGPR120 activity, and col. 24 (stating it was one of the “most active” compounds discovered having “significant agonistic activity on GPR120 and GPR40…”.
The examiner interprets DFL23917 as an embodiment of claims 11-12.
One of skill in the art would at once envisage the subject matter of claims 1-2, 4-8 and 11-12, comprising administering the active DFL23917, for the same reasons stated that one of skill in the art would at once envisage the subject matter of claims 1-8 regarding the administration of DFL23914.
Accordingly, claims 1-8 and 11-12 are anticipated by US’090.
Regarding claims 9 and 10, as discussed earlier the disclosed active DFL24102 is named specifically in claims 2 and 9. Claim 10 recites its pharmaceutical composition.
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DFL24102
The active DFL24102 is indeed encompassed by the general Markush grouping of chemicals disclosed in US’090. See US’090 at 33, claim 1, and note that the R 1-3 variables may be a phenyl or a five-membered ring heterocycle, both of which are aromatic rings. See also, US’090 at claim 3, wherein the first five-membered ring heterocycle listed for the R variables is “thienyl”. Looking at the deceptively large Markush structure recited in claim 1 of US’090, perhaps one might interpret the broad generic formula recited in claim 1 of US’090 as seeming to describe an infinite number of compounds, and possibly may not immediately recognize that DFL24102 was indeed encompassed and taught by the claim.
However, the inventors of US’090 patented the analogous compound, wherein the five-membered ring heterocycle of DFL24102 (thienyl) was instead phenyl. See, e.g., US’090 at col. 33, claim 1 (general Markush structure), cols. 34 and 36, claims 8-9 (dependent on claim 1, and respectively reciting as the nineth and seventh compound “7-(3-(N-(6-fluoro-4-methyl-[1,1′-biphenyl]-3-yl)sulfamoyl)phenyl)heptanoic acid”, which is DFL23916). As discussed in the 112(b) section, DFL23916 is recited in the instant claim 2 as the fourth compound. It has a CAS Reg. No. of 2185867-25-6, and is represented by the following chemical structure:
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DFL23916
See also, US’090 at col. 13, Example 9 (providing the synthesis of DFL23916 and designating it compound 9), col. 25, Table 1, providing its chemical structure and hGPR120 activity, and col. 24 (stating it was one of the “most active” compounds discovered having “significant agonistic activity on GPR120 and GPR40…”.
Further, and importantly, compared to DFL23917 discussed just a page ago, the active DFL23916 exhibited superior hGPR120 activity (11.2 vs. 16.5 μM values respectively reported for the DFL23916 and DFL23917, see US’090 at col. 25, Table 1, compounds 9 and 10).
One of skill in the art, reading US’090, would interpret the enhancement in activity towards the hGPR120 receptor by simply changing the location of the aromatic ring as teaching a structure activity relationship around the hGPR120 receptor, wherein the preferred orientation for the aromatic ring was as depicted for DFL23916.
One of skill in the art, reading US’090, would learn that a thienyl was a preferable replacement for phenyl. See, e.g., US’090, col. 5, stating “[m]ore preferably, the five-membered ring heterocycle is selected from the group comprising thienyl…”. It was indeed described as the very first preferable five-membered ring heterocycle replacement. One of skill in the art would not disregard this fact as mere coincidence caused by perhaps listing different substituents in alphabetical order. Moreover, it is recited as the first option in claim 3.
One of skill in the art, reading US’090, would therefore interpret US’090 as teaching a more limited number of compounds covered by the preferred formula (I), with a large unchanging structural nucleus for the active, pharmaceutically significant compounds that bore the R 1-3 variables within the configuration of DFL23916.
Combined with the fact that claim 3 further narrows this configuration, and replaces the phenyl substituent with a five-membered ring heterocycle, this more narrow configuration lists thienyl as the first option, which one of skill in the art reading US’090 would find as significant, because the variables are not recited in alphabetical order. Moreover, thienyl is described in the specification as the first preferred five-membered ring heterocycle.
There were technically three compounds that result from replacing the phenyl of DFL23916 with a preferred thienyl, as indicated by the preferred configuration one of skill in the art would learn from reading US’090. See stars located at the thiophene depicted below, indicating two possible connections. The third is at the sulfur atom.
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Possible connections to thiophene marked by *, discussed above
One of skill in the art, reading US’090, would at once envisage the active compound DFL24102, as if the inventors of US’090 had written it by name. Following the same logic as discussed for the other actives already patented in US’090, one of skill in the art, reading US’090, would at once envisage the subject matter of claims 1-12. The above analysis for DFL24102 is summarized in the below figure.
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Accordingly, claims 1-12 are anticipated by US’090.
The examiner notes that in claim 1 of US’090, its inventors expressly teach halo and methyl substitution for the phenyl and thienyl groups. This is relevant to the instant claims 11-12, which under one interpretation, recite substitution just at these locations.
Claims 1-12 Anticipated by US’090 as Evidenced by Yang 2021 and CN’728
Claim(s) 1-12 is/are rejected under both 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US’090 as Evidenced by Yang 20212 and CN’728.3
The entire rejection of claims 1-12 is restated herein and applied in full.
To the discussion, Yang 2021 is applied as evidence that GPR120 agonists were known to be indicated for treating colitis. The same experiment is taught throughout that applicant utilizes for its data. E.g., DSS induced colitis model, active administered was the active administered in the Oh D. Y. et al., Nat Med (2014), 20: p 942-7 paper cited in US’090. The Oh D. Y. paper referenced in US’090 is also cited in the IDS received on 09/06/2024 as NPL cite K, which is attached hereto to make it a clearer part of the record.
In the same vein, CN’728 is applied as further evidence that GPR120 agonists were known to be indicated for treating colitis. CN’728 specifically indicates such compounds for treating Crohn's disease (see claim 4, translation page 2).
Accordingly, claims 1-12 are anticipated by US’090 as Evidenced by Yang 2021 and CN’728.
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 1-12 Obvious over US’090 as Evidenced by Yang 2021 and CN’728
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US’090 as Evidenced by Yang 2021 and CN’728.4
The rejection of claims 1-12 under both 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US’090 as Evidenced by Yang 2021 and CN’728 is fully incorporated herein.
As discussed, US’090 explicitly discloses many of the recited actives. One of skill in the art, reading US’090 alone, would at once envisage the active DFL24102, as if the inventors of US’090 had written the compound by name.
Further, as discussed, one of skill in the art, reading US’090, would at once envisage claims 1-12.
Accordingly, one of ordinary skill in the art at the time of filing would have a reasonable expectation of success in preparing these compounds, and administering them in the recited methods, because US’090 teaches these compounds and their activity as agonists towards GPR120. Moreover, as discussed, the idea of administering a GPR120 agonist for treating IBD and related conditions was already known at the time of filing. Therefore, one of ordinary skill in the art at the time of filing would have a reasonable expectation of success in treating or preventing the recited conditions because GPR120 agonists were already indicated for such patients.
Therefore, claims 1-12 were obvious at the time of filing.
Secondary Considerations
While secondary considerations are not relevant to the anticipation analyses, such considerations are pertinent to the obviousness rejections. The examiner expects that Applicant will assert secondary considerations relating to pharmacokinetics observed from administering select actives to mice in the induced-colitis experiments. See, e.g., Specification at 2-3 (discussing possible secondary considerations):
These compounds, upon oral administration, are poorly absorbed and concentrate in the ileum and colon at high concentrations and are thus able to effectively act locally to prevent or treat inflammatory bowel disease.
Furthermore, the present inventors have found that these compounds, differently from other known GRP120 agonists, do not cause internalization and degradation of GPR120 upon binding and activation of the receptor and therefore are able to elicit and maintain a potent agonistic activity.
Specification at 2-3.
The examiner acknowledges that Applicant’s instant reports regarding administration of select actives it already disclosed in US’090 show some promising pharmacokinetics. However, the disclosed pharmacokinetics pertain to mice. Applicant has not shown that these pharmacokinetics extend to humans. Therefore, the disclosed data are not compelling to overcome the obviousness of the claims.
Further, the mice pharmacokinetics are inherent properties of the already known/obvious pharmaceutical compositions of the actives. As discussed, the pharmaceutical compositions administered to these mice were either explicitly taught in US’090, or were obvious over US’090. For those unfamiliar with these experiments, the mice pharmacokinetics are just a measurement that benchmarks the performance of pharmaceutical compositions in standard animal model experiments. The instant claims are just drawn to observations from these inherent properties.
It is not novel to simply follow every teaching in the art and report the results. Instead, it is clear indicia of obviousness.
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.
NSDP to US’090
Claims 1-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8, 9, 10, 11 and 12-15 of U.S. Patent No. US 10508090 B2, i.e., US’090 cited in the anticipation and obviousness sections.
Although the claims at issue are not identical, they are not patentably distinct from each other because US’090 at claims 8 and 9 teaches the same actives recited in the instant claim 2, and US’090 at claims 10-11 teaches administration for effectively the same purpose, i.e., treating inflammation in the gastrointestinal system by GPR120 agonism. The compound DFL24102, recited in the instant claim 9, is clearly encompassed by claims 1 and 3 of US’090. The pharmaceutical compositions taught in US’090 (claims 12-15) all overlap with those instantly claimed in claims 5-8. The particular substitution recited in instant claims 11-12 is taught by US’090 at claim 1.
Accordingly, one of ordinary skill in the art at the time of filing the application that led to the US’090, and in possession of its subject matter, would have a reasonable expectation of success in obtaining the subject matter of the instant claims 1-12, because the actives, pharmaceutical compositions, and indications were already in his possession.
Accordingly, claims 1-12 are unpatentable over claims 1, 3, 8, 9, 10, 11 and 12-15 of U.S. Patent No. US 10508090 B2.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christopher Evan Redwood whose telephone number is (571) 272-8882. The examiner can normally be reached Monday - Friday 6:15 AM - 4:45 PM.
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/C.E.R./ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
1 Maria De Pizzol, “Sulfonamides As GPR40- And GPR120-agonists”, U.S. Patent No. US 10508090 B2, published 2019-12-17, Applicant DOMPÉ FARMACEUTICI S.P.A., hereinafter “US’090”.
2 Yang, Wenjing, et al. "GPR120 inhibits colitis through regulation of CD4+ T cell interleukin 10 production." Gastroenterology 162.1 (2022): 150-165, published online Sept. 16, 2021, cited in IDS received on 09/06/2024 as NPL cite R, hereinafter “Yang 2021”.
3 LIANG XINMIAO, et al., “Naturally Derived FFA4 (GPR120) Receptor Agonist And Application Thereof”, Chinese Patent Application Publication No. CN 111317728 A, published 2020-06-23, cited in IDS received on 09/06/2024 as FOR cite A, hereinafter “CN’728”. An English translation of this publication obtained from Google Translate is annexed hereto.
4 The references and citations are the same as provided in the section regarding anticipation.
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