DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
The Patent Office has transferred this application to a different examiner. Please direct any reply to the examiner now identified on the cover sheet.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Preliminary Amendment filed 11 January 2024, Applicant cancelled claim 13 and amended claims 1-12 and 14-15. Claims 1-12 and 14-15 are pending.
Restriction/Election
The examiner acknowledges Applicant’s election with traverse of Group II (claims 8-12 and 14). Reply (24 April 2026) at page 1. Applicant argues “there would be no search burden in searching all of the groups together.” Id.
In response, the examiner notes that this application entered the U.S. national stage under 35 U.S.C. 371 and, therefore, is subject to unity of invention practice in accordance with 37 CFR 1.475 and 1.499. MPEP § 1896(III) and § 1893.03(d). “When making a lack of unity requirement, the examiner must (1) list the different groups of claims and (2) explain why each group lacks unity with each other group (i.e., why there is no single general inventive concept) specifically describing the unique special technical feature in each group.” MPEP § 1893.03(d). In the previous Office action (04 March 2026), the Patent Office applied WO 2005/107462 A2 and concluded that unity of invention is lacking among Groups I, II, and III. Pages 3-4. Because Applicant’s argument fails to challenge the Patent Office’s conclusion that unity of invention is lacking, it is not persuasive.
The restriction requirement is made FINAL.
Pursuant to 37 CFR 1.142(b), the claims directed to non-elected Group I (claims 1-7) and non-elected Group III (claim 15) are withdrawn from consideration.
Claims 8-12 and 14 are considered below.
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Claim 10, which depends on claim 8, recites that the FWHM is “between about 0.85-0.90° (2θ).” That range conflicts with the FWHM range recited in the second wherein clause of claim 8, i.e., “below 0.85° (2θ).” However, the first and second wherein clauses of claim 8 are linked by “and/or.” This raises the following query: Does claim 10 implicitly require both (i) that the first wherein clause of claim 8, which concerns “a mass increase of 1.3% or less,” is selected and (ii) the second wherein clause of claim 8 is non-selected? It is unclear what the answer is. If it is “yes,” the foregoing selection and non-selection must be positively recited in claim 10 to resolve this ambiguity and, thereby, bring the claim into compliance with 35 U.S.C. 112(b). If it is “no,” then claim 10 must be redrafted in independent form to resolve the ambiguity and, thereby, bring the claim into compliance with 35 U.S.C. 112(b) and 112(d).
Claim Rejections - 35 U.S.C. 112(d)
The following is a quotation of 35 U.S.C. 112(d):
Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) as being in improper dependent form.
Claim 12, which depends on claim 8, recites that “the FWHM is measured by manual mode or by automatic mode.” However, claim 12 covers the entire universe of modes because there is no mode other than the following two modes: manual and automatic. Therefore, claim 12 does not specify a further limitation of the subject matter of claim 8 and, consequently, fails to comply with 35 U.S.C. 112(d).
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 U.S.C. 102 / 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 8-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as unpatentable over Bay (WO 2008/028859 A1).
Bay is directed to “new methods for the synthesis of N-( 8-[2-hydroxybenzoyl]-amino) caprylic acid and its sodium salts.” Page 1 at lines 1-2.
Example 2 of Bay (pages 10-11) is especially relevant to Applicant’s claims because the specification of the present application, as originally filed (WO 2023/285581), states:
SNAC polymorphic form A may be prepared according to Example 2 of WO 2008/028859. SNAC polymorphic form A exhibits an X-ray powder diffraction pattern comprising peaks at angles of diffraction 2Theta (2θ) of 3.0±0.2°, 6.0±0.2, 8.7±0.2°, 11.6±0.2°, 14.6±0.2°, and 18.9±0.2° measured using CuKa radiation. As described in WO 2008/028859, N-[8-(2-hydroxybenzoyl)-amino]caprylic acid is reacted with a molar excess of sodium salt to form SNAC. As the reaction is carried out in an aqueous solvent a trihydrate form of SNAC is formed and then converted into form A by drying under reduced pressure. The drying step may be carried out in an oven under vacuum as described in WO 2008/028859.
Page 4 at lines 24-31 (emphasis added).
In Example 2 of Bay, “[t]he resulting white solid [SNAC] was transferred to a crystallization dish and was dried at 35 °C for 6 hours and at 90 °C with nitrogen bleeding for additional 18 hours.” (Emphasis added) Page 11 at lines 16-18. Referring to claim 8 of the present application, Bay is silent regarding (i) the mass increase/moisture absorption of Example 2 when subjected to an increase in relative humidity and (ii) the FWHM of Example 2 at the peak at angles of diffraction 2Theta (2θ) of 8.7±0.2°.
Nevertheless, the specification of the present application states: “During testing and development of an up-scaled process, the inventors have surprisingly found that heating SNAC polymorphic form A at a temperature of above 90 °C, such as at a temperature about 105-140 °C, for at least about 5 minutes, such as for at least about 15 minutes results in a notable reduction in crystal imperfections.” (Emphasis added) Page 5, lines 14-17; see also page 19 at lines 23-26 (“heating, optionally under reduced pressure, the monosodium N-[8-(2-hydroxybenzoyl)-amino]caprylate at a temperature of above 90 °C, such as at a temperature of about 105-140 °C, for at least about 5 minutes, such as for at least about 15 minutes”) and page 21 at lines 6-9 (same).
Applying the definition of the adverb <about> set forth on page 16 (lines 20-25) of Applicant’s specification, even the exemplary temperature of “about 105 °C” encompasses temperatures as low as 94.5 °C.
At this juncture, it is important to recognize 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.” (Emphasis added) MPEP § 2112.01(I), citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977). The disclosure from Applicant’s specification provides a sound basis for the examiner’s position that the process of Example 2, which employs heating at 90 °C with nitrogen bleeding for 18 hours, yields a SNAC polymorphic Form A that at least substantially satisfies all the corresponding property limitations recited in claim 8 and the claims depending thereon. Moreover, Table 4 of Applicant’s specification (page 30) shows that Batch 4, made using the process of Example 2 of Bay, even satisfies the claimed moisture absorption and FWHM properties before the step of heat treatment, as does Batch 9 of Table 5 (pages 31-32). MPEP § 2112(V) (“once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant”).
Although Bay is silent as to the XRPD pattern, moisture absorption, and FWHM of the SNAC polymorph A of Example 2, Applicant’s determination of those properties does not render the claimed invention patentable, even if one or more of them is advantageous. MPEP § 2112(I) (“‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’”), quoting Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Applicant is reminded that “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” MPEP § 2112(II) (emphasis in original), citing Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003).
In sum, claims 8-12 are anticipated or rendered prima facie obvious by Bay. MPEP § 2112(III) (“Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”).
Regarding claim 14, Applicant is referred to page 8 (lines 24-36) of Bay.
Claims 8-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as unpatentable over Levchik (WO 2005/107462 A2).
Levchik is directed to “crystalline polymorphic forms of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate ("SNAC"), including two hydrates, a methanol solvate, and an ethanol solvate, of SNAC.” Abstract. “More specifically, the present invention provides six polymorphic forms of SNAC (hereafter referred to as Forms I-VI).” Id.
In Example 4 (page 36), Levchik discloses: “Form IV was prepared by heating Form II for 3 hours in a dry air oven at 170° C. The Form IV prepared had a melting point onset according to DSC of about 198° C, and XRPD, DSC, TGA, FTIR, and sorption/desorption spectra as shown in Figures 16-20.” Emphasis added. Figure 16, which is the XRPD pattern of Example 4 (Form IV), is reproduced below:
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Figure 16 of Levchik closely resembles Figure 1 of the present application, which Applicant identifies as “an X-ray Powder Diffraction ‘XRPD’ pattern of SNAC polymorphic form A exhibiting a mass increase of less than 1.0 % when subjected to an increase in relative humidity from about 0% to about 65 % RH at 25 °C as determined by DVS.” Page 4 at lines 1-4.
The specification of the present application states: “During testing and development of an up-scaled process, the inventors have surprisingly found that heating SNAC polymorphic form A at a temperature of above 90 °C, such as at a temperature about 105-140 °C, for at least about 5 minutes, such as for at least about 15 minutes results in a notable reduction in crystal imperfections.” (Emphasis added) Page 5, lines 14-17; see also page 19 at lines 23-26 (“heating, optionally under reduced pressure, the monosodium N-[8-(2-hydroxybenzoyl)-amino]caprylate at a temperature of above 90 °C, such as at a temperature of about 105-140 °C, for at least about 5 minutes, such as for at least about 15 minutes”) and page 21 at lines 6-9 (same).
At this juncture, it is important to recognize 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.” (Emphasis added) MPEP § 2112.01(I), citing In re Best, 562 F.2d 1252, 1255 (CCPA 1977). The disclosure from Applicant’s specification provides a sound basis for the examiner’s position that the process of Example 4 of Levchik, which employs heating at 170 °C for 3 hours, yields a SNAC polymorph that at least substantially satisfies all the corresponding property limitations recited in claim 8 and the claims depending thereon. Figure 16 of Levchik provides additional support for the examiner’s position. MPEP § 2112(V) (“once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant”).
Although Levchik is silent as to the moisture absorption and FWHM of the SNAC polymorph of Example 4, Applicant’s determination of those properties does not render the claimed invention patentable, even if one or both of them is advantageous. MPEP § 2112(I) (“‘[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.’”), quoting Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Applicant is reminded that “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” MPEP § 2112(II) (emphasis in original), citing Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003).
In sum, claims 8-12 are anticipated or rendered prima facie obvious by Levchik. MPEP § 2112(III) (“Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”).
Regarding claim 14, Applicant is referred to page 25 (lines 12-18) of Levchik.
Conclusion
Claims 8-12 and 14 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
23 June 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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