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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Claim Status
Claims 25-31 and 35 are pending. Claim 25 has been amended. Claims 25-31 and 35 are being examined in this application. In the response to the restriction requirement, Applicants elected SEQ ID NO: 2 (PYY), SEQ ID NO: 10 (GLP-1 analog), and injection.
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.
This rejection is maintained.
Claims 25-26, 28-31 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cowley et al. (US 8058233).
With respect to claim 25, Cowley et al. teach a method of decreasing calories intake, food intake or appetite (i.e. inducing satiation) comprising administering PYY3-36 and GLP-1 or an analog thereof (claim 1), wherein the administration is oral or sublingual (claim 7).
With respect to the limitation “wherein the method does not substantially increase a plasma concentration of PYY and GLP-1 or analog thereof in the subject”, the instant specification teaches that “[t]reatments using the combination of PYY and Ex-4, either by gene expression, or by administration of a combination of PYY and Ex-4 via topical administration, spray, oral formulations (sprays, lozenges, dissolvable films, orally disintegrating tablets, buccal dosage forms and the like) do not detectably increase plasma levels of PYY or Ex-4” (page 27, 2nd para). Therefore, since the administration of the method taught by Cowley et al. is the same administration instantly claimed, it would not increase the plasma concentration of PYY or GLP-1 or analog thereof in the subject.
With respect to claim 26, it is noted that PYY3-36 corresponds to instantly claimed SEQ ID NO: 2.
With respect to claim 28, Cowley et al. teach that the PYY3-36 and the GLP-1 or agonist thereof are administered sequentially (i.e. separately) (claim 2).
With respect to claims 29-30, given the finite possibilities, one of ordinary skill in the art would have at once envisaged administering: 1) the PYY3-36 first and the GLP-1 or analog thereof second; and 2) the GLP-1 or analog thereof first and the PYY3-36 second.
With respect to claim 31, Cowley et al. teach that the PYY3-36 and the GLP-1 or analog thereof are administered simultaneously (claim 13).
With respect to claim 35, Cowley et al. teach that the PYY3-36 and the GLP-1 or analog thereof are administered at least 30 minutes prior to a meal (claims 10 and 20), and further teaches that the PYY or an analog thereof is administered slightly prior to whenever the effect is desired, such as, but not limited to about 10 minutes, about 15 minutes, about 30 minutes, about 60 minutes, about 90 minutes, or about 120 minutes, prior to the time the effect is desired (column 16, lines 43-48).
Response to Arguments
Applicant’s arguments filed on 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues that “[C]owley fails to teach topical lingual delivery of an orally disintegrating tablet (ODT) of PYY and GLP-1, and much less, to show that such delivery necessarily results in a therapeutic effect without a change in the plasma level of the agent”.
Applicant also argues that “[e]ven if the Cowley's administration of PYY and GLP-1 would result in increased plasma concentration, that increase would eventually return back to normal, Applicant asserts that the claim should be interpreted to mean that the claimed method does not increase the plasma level of PYY or GLP-1 to a detectable increase in level at any time. This is consistent with the teachings of the application that the claimed method does not, at any point, result in a detectable increase in the plasma level of PYY or GLP-1”.
Applicant’s arguments are not persuasive.
First of all, it is clear from the teachings of Cowley that the administration is oral or sublingual (see claim 7).
Furthermore, Cowley also teaches that for oral administration, the pharmaceutical compositions can take the form of tablets comprising disintegrants (column 20, lines 27-35), thus reading on the claimed “orally disintegrating tablet that is topically administered to a subject's tongue”.
Moreover, the MPEP 2112.01 states that “'[P]roducts of identical chemical composition cannot have mutually exclusive properties.’ A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The MPEP 2111.01 further states that “[W]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.)”.
In the instant case, the teachings of Cowley relate to a method of inducing satiation comprising administering sublingually PYY3-36 and GLP-1 or an analog thereof (claims 1 and 7).
It is noted that Cowley also teaches that, for oral administration, the pharmaceutical compositions can take the form of tablets comprising disintegrants (column 20, lines 27-35), thus reading on the claimed "orally disintegrating tablet that is topically administered to a subject's tongue".
The method of Cowley et al. is the exact method instantly claimed; thus, it would inherently NOT increase a plasma concentration of PYY and GLP-1 or analog thereof in the subject.
This is further evidenced by the instant specification, which teaches that "[t]reatments using the combination of PYY and Ex-4, either by gene expression, or by administration of a combination of PYY and Ex-4 via topical administration, spray, oral formulations (sprays, lozenges, dissolvable films, orally disintegrating tablets, buccal dosage forms and the like) do not detectably increase plasma levels of PYY or Ex-4" (page 27, 2nd para), and further teaches that "[P]YY produced by salivary glands or applied topically to the mouth do not result in systemic increase in PYY, but instead provides therapeutic effect by acting locally" (Example 2).
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
Claims 25-31 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Cowley et al. (US 8058233) in view of Bossart et al. (WO 2017/009236).
The teachings of Cowley et al with respect to claims 25-26, 28-31 and 35 have been discussed above.
Cowley et al. do not teach that the GLP-1 analog is Exendin-4 (SEQ ID NO: 10).
Bossart et al. teach that compared to GLP-1, glucagon and Oxyntomodulin, exendin-4 has beneficial physicochemical properties, such as solubility and stability in solution and under physiological conditions, which results in a longer duration of action in vivo (para bridging pages 26-27).
It would have been obvious to one of ordinary skill in the art to use exendin-4 as the GLP-1 analog in the method of Cowley et al. because Bossart et al. teach that compared to GLP-1, glucagon and Oxyntomodulin, exendin-4 has beneficial physicochemical properties, such as solubility and stability in solution and under physiological conditions, which results in a longer duration of action in vivo.
One of ordinary skill in the art would have reasonably expected exendin-4 to have a longer duration of action in vivo when used in the method of Cowley et al.
Response to Arguments
Applicant’s arguments filed on 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues that “[B]ossart, cited for its purported disclosure of exendin-4, does not remedy the deficiencies of Cowley”.
Applicant’s arguments are not persuasive.
Applicant arguments have been addressed above under “Response to Arguments” in the rejections under 35 U.S.C. 102(a)(1) above.
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
Claims 25-26, 28-31 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9492505 in view of Cowley et al. (US 8058233).
With respect to claim 25, ‘505 teaches a method of inducing satiation in a subject comprising applying a therapeutically effective dose of a satiation gut peptide to a tongue in a mouth of a subject, wherein the satiation gut peptide is contained within a lozenge, wherein the lozenge is in the form of a dissolvable planar sheet, wherein said satiation gut peptide consists essentially of Peptide YY (PYY), and wherein the application of the dissolvable planar sheet to the tongue does not substantially change the concentration of the satiation peptide in the plasma of the subject (claims 1-2).
‘505 does not teach administering GLP-1 or an analog thereof.
Cowley et al. teach a method of decreasing calories intake, food intake or appetite (i.e. inducing satiation) comprising administering PYY3-36 and GLP-1 or an analog thereof (claim 1), wherein the administration is oral or sublingual (claim 7).
The MPEP 2144.06 states that it is obvious to substitute equivalents known for the same purpose, and it further states that "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 Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from their having been individually taught in prior art.
Therefore, since the references teach that PYY and GLP-1 or an analog thereof are effective in inducing satiation, it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in inducing satiation. Thus, combining them flows logically from their having been individually taught in prior art.
With respect to claim 26, it is noted that PYY3-36 corresponds to instantly claimed SEQ ID NO: 2.
With respect to claim 28, Cowley et al. teach that the PYY3-36 and the GLP-1 or agonist thereof are administered sequentially (i.e. separately) (claim 2).
With respect to claims 29-30, given the finite possibilities, one of ordinary skill in the art would have at once envisaged administering: 1) the PYY3-36 first and the GLP-1 or analog thereof second; and 2) the GLP-1 or analog thereof first and the PYY3-36 second.
With respect to claim 31, Cowley et al. teach that the PYY3-36 and the GLP-1 or analog thereof are administered simultaneously (claim 13).
With respect to claim 35, Cowley et al. teach that the PYY3-36 and the GLP-1 or analog thereof are administered at least 30 minutes prior to a meal (claims 10 and 20), and further teaches that the PYY or an analog thereof is administered slightly prior to whenever the effect is desired, such as, but not limited to about 10 minutes, about 15 minutes, about 30 minutes, about 60 minutes, about 90 minutes, or about 120 minutes, prior to the time the effect is desired (column 16, lines 43-48).
Response to Arguments
Applicant’s arguments filed on 10/29/2025 have been fully considered but they are not persuasive.
Applicant arguments have been addressed above under “Response to Arguments” in the rejections under 35 U.S.C. 102(a)(1) and 103 above.
For the reasons stated above the rejection is maintained.
This rejection is maintained.
Claims 25-31 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9492505 in view of Cowley et al. (US 8058233) and Bossart et al. (WO 2017/009236).
The teachings of ‘505 and Cowley et al. with respect to claims 25-26, 28-31 and 35 have been discussed above.
‘505 and Cowley et al. do not teach that the GLP-1 analog is Exendin-4 (SEQ ID NO: 10).
Bossart et al. teach that compared to GLP-1, glucagon and Oxyntomodulin, exendin-4 has beneficial physicochemical properties, such as solubility and stability in solution and under physiological conditions, which results in a longer duration of action in vivo (para bridging pages 26-27).
It would have been obvious to one of ordinary skill in the art to use exendin-4 as the GLP-1 analog in the method obvious over ‘505 and Cowley et al. because Bossart et al. teach that compared to GLP-1, glucagon and Oxyntomodulin, exendin-4 has beneficial physicochemical properties, such as solubility and stability in solution and under physiological conditions, which results in a longer duration of action in vivo.
One of ordinary skill in the art would have reasonably expected exendin-4 to have a longer duration of action in vivo when used in the method obvious over ‘505 and Cowley et al.
Response to Arguments
Applicant’s arguments filed on 10/29/2025 have been fully considered but they are not persuasive.
Applicant arguments have been addressed above under “Response to Arguments” in the rejections under 35 U.S.C. 102(a)(1) and 103 above.
For the reasons stated above the rejection is maintained.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658