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 .
Terminal Disclaimer
The terminal disclaimer filed on 07/30/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application Numbers 18/578,902 and 18/579,262 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
The objections to the specification are withdrawn in view of the amendments to the
specification.
The objection to claim 1 is withdrawn in view of the cancellation of the claim amendments.
The objections to claims 4-5 and 12-13 are withdrawn in view of the cancellation of the claims.
The rejections of claims 3-5, 11-13, and 16 are withdrawn in view of the cancellation of the claims.
The rejections of claims 1-2, 7, 9-10, and 15 under 35 U.S.C. § 112(a) are withdrawn in view of the claim amendments.
The rejections of claims 1-2, 7, 9-10, and 15 under 35 U.S.C. § 112(b) are withdrawn in view of the claim amendments.
The previous rejections of claims 1-2, 7, 9-10, and 15 under 35 U.S.C. § 103 are withdrawn in view of the claim amendments.
The non-statutory double patenting rejections of 1-2, 7, 9-10, and 15 over the claims of copending Application Nos. 18/578,902 and 18/579,262 are withdrawn in view of the filed terminal disclaimer and request for reconsideration.
Claim Status
Applicants' amendments and arguments filed 07/30/2026 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 3-5, 11-13, and 16 are cancelled.
Claims 6, 8, 14, and 17-20 are withdrawn.
Claims 1-2, 7, 9-10, and 15 are under current examination. The claims were read in view of the species election of a salt of an organic material, specifically the sodium salt of deoxycholic acid, in the reply filed on 02/17/2026.
Claim Interpretation
Independent claims 1 and 9 are directed to products of amorphous nano-molecular associations; the claims recite product-by-process limitations. Claim 1 recites (emphasis added) “An amorphous nano-molecular association prepared by dissolving an organic material, an inorganic material, or a salt thereof in a solvent to form a solution, and applying shear stress to the solution…” and claim 9 recites (emphasis added) “An amorphous nano-molecular association prepared by dissolving a salt of an organic material or a salt of an inorganic material in a solvent to form a solution, and applying shear stress to the solution …”. Per MPEP 2113, “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)”.
The specification does not set forth a definition of “amorphous nano-molecular association” and this does not appear to be a term commonly used in the art. The Examiner broadly interprets that an amorphous form of the elected species of sodium deoxycholic acid formed through non-covalent association with a particle size of 50 nm or less reads on the independent claims. Absent evidence to the contrary, the Examiner interprets that the process recited does not further structurally limit the claimed product.
New Rejections, Necessitated by Claim Amendments
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 1-2, 7, 9-10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2001/0024658 A1, published September 27th, 2001; of record), hereafter “Chen”, in view of Mukhopadhyay et al. (“Chemistry and biology of bile acids” Current Science 2004, 87, 1666-1683), hereafter “Mukhopadhyay”, as evidenced by Hubbard et al. (“Hydrogen Bonds in Proteins: Role and Strength”, Encyclopedia of Life Sciences 2010 John Wiley & Sons, Ltd., 1-7), hereafter “Hubbard”.
Regarding instant independent claims 1 and 9, Chen teaches a pharmaceutical dosage form comprising a bile salt (abstract, claim 1), wherein the bile salt is a salt of deoxycholic acid (claim 29). Salt forms include sodium salts (paragraph [0068]), and Chen exemplifies the use of sodium deoxycholic acid (Example 1 at paragraph [0151]; Example 15). The bile salt is taught to be amorphous (claims 18-19 and 44; paragraphs [0036], [0071]). Compositions and dosage forms can be processed and prepared according to conventional techniques known to those skilled in the art (paragraph [0125]). Chen teaches that the composition forms particles upon dilution in an aqueous medium and that preferably, the average particle size is less than about 200 nm, more preferably less than about 100 nm, still more preferably less than about 50 nm and most preferably less than about 20 nm (paragraph [0117]), overlapping the claimed range. Per MPEP 2144.05 I., “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. Chen teaches that the bile salt can be present as either an integral part of the composition or separate, as a coating (paragraph [0071]), suggesting that the amorphous bile salt does not require other components (“consists of” the bile salt).
Chen does not explicitly teach that the association is formed through noncovalent association (instant claims 1 and 9) or an intermolecular distance of 10 Å or less (instant claims 7 and 15). Mukhopadhyay teaches that bile salts have a rigid steroid backbone having polar hydroxyl groups on the concave α-face and methyl groups on the convex β-face, which enables them to aggregate in aqueous media in a manner largely driven by the hydrophobic association of apolar β-faces of steroid backbones, while further aggregation occurs through hydrogen bonding interactions (see pg. 1673, column 2, paragraph 2, and Figures 2 and 8). As evidenced by Hubbard, a detailed analysis of hydrogen-bonding geometry showed that the distance between donated protons and acceptors (O or N) is always greater than 1.6 Å and less than 2.5 Å (pg. 2, column 1, paragraph 2) and that a hydrogen bond can be inferred when the distance between donor and acceptor is less than 3.5 Å (pg. 2, column 2, paragraph 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention that the particles comprising amorphous sodium deoxycholic acid dispersed in water taught by Chen would comprise molecules with noncovalent associations including hydrogen-bonded molecules with an intermolecular distance of 3.5 Å or less, overlapping the claimed range, as suggested by Mukhopadhyay. Mukhopadhyay teaches that bile salts aggregate in aqueous media via non-covalent interactions including hydrogen bonding, generally accepted as being a distance of 3.5 Å or less, and shows that deoxycholic acid is a known bile acid (see Chart 1 on pg. 1670). Chen similarly teaches particles of sodium deoxycholic acid dispersed in water; from the teachings of Mukhopadhyay, one of ordinary skill in the art would recognize that the amorphous sodium deoxycholic acid of Chen is able to undergo hydrogen bonding with intermolecular distances of 3.5 Å or less.
The limitations of claims 2 and 10 are measured properties of the claimed amorphous nano-molecular associations which do not further structurally limit the claimed associations. As described above, the structural components of the claimed associations are rendered obvious by the teachings of Chen and Mukhopadhyay; absent evidence to the contrary, the claimed measured properties will be present. Per MPEP 2112.01 II., “ A chemical composition and its properties are inseparable” and per MPEP 2112.01 I, “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)”.
Rejections Maintained, Slightly Modified to Address Amended Claims
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 7, 9-10, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 11 of copending Application No. 18/421,490 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Both the instant claims and those of co-pending Application 18/421,490 are directed to amorphous nano-molecular associations of an organic or inorganic material which consist of the material. Both sets of claims recite that the material is sodium salt of deoxycholic acid, the same particle diameter, and the same intermolecular distances. Both sets of claims recite that the associations are prepared by substantially the same process (dissolving the material in a solvent and bringing the molecules in close proximity to each other recited in the copending claims).
The claims of co-pending Application 18/421,490 do not recite the HPLC, NMR, or FT-IR result values of the instant claims. However, both sets of claims recite the same associations made by a substantially identical process, and thus, the associations will necessarily have the same properties; per MPEP 2112.01 II, “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. Id.” Further, per MPEP 2112.01 I., “Where 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)”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants’ arguments filed 07/30/2026 have been fully considered.
Regarding the objections and claims rejections under 35 U.S.C. § 112, Applicant argues that the amended claims have rendered the objections and rejections moot. Regarding the expression “intermolecular distance” of claims 7 and 15, Applicant argues that this expression refers to distance between molecules within a single association.
As noted above, the claim objections and rejections under 35 U.S.C. § 112 have been withdrawn. In view of the amendment to claim 1 that the nano-molecular association is formed through noncovalent association, the Examiner agrees that one of ordinary skill in the art would under understand that the “intermolecular distance” refers to distance between molecules within a single association.
Regarding the claim interpretation, Applicant argues that the applied shear-stress process inherently imparts a distinct, distinguishable physical structure to the final product supported by analytical data in the specification (1H NMR, FT-IR, and HPLC), which demonstrate clear differences from the untreated starting material. Additionally, Applicant argues that claims 1 and 9 have been amended to recite that association consists of the organic material, the inorganic material, or the salt thereof, and that the association consists of the salt of the organic material or the salt of the inorganic material, respectively, further expressly describing the distinguishing structural feature, rendering the claim interpretation moot.
In response, the Examiner notes that the amended claims continue to recite product-by-process limitations, regardless of the amended structural features. Per MPEP 2113, “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)”. As set forth above, the product is obvious from a product of the prior art; specifically, Chen teaches amorphous sodium deoxycholic acid particles, and that compositions can be prepared according to conventional techniques known to those skilled in the art (paragraph [0125]). While the data in the specification demonstrates that the claimed product is distinguishable from the starting material, it does not demonstrate that the product is distinguishable from amorphous associations known in the art made by a different process.
Regarding the claim rejections under 35 U.S.C. § 103, Applicant argues that the amended claims to recite the “consists of” language distinguishes the claimed invention from Chen, who discloses pharmaceutical dosage forms with bile salts that form particles upon dilution in an aqueous medium. The claimed nano-molecular association is uniquely prepared by applying shear stress, resulting in noncovalently associated molecules with specific analytical properties that differ from the pre-association material; on the contrary, Chen relies on a bile salt/surfactant formulation, whereas the claimed amorphous nanomolecular association specifically addresses and overcomes the limitations of such surfactant/polymer-based encapsulation methods. Applicant argues that Li does not remedy the deficiencies of Chen.
These arguments are unpersuasive. While Chen teaches a pharmaceutical dosage form comprising multiple components, the sodium deoxycholic acid bile salt is taught to be in amorphous form, and Chen teaches that the bile salt or acid can be present as either an integral part of the composition or separate, as a coating (paragraph [0071]), suggesting that the amorphous bile salt does not require other components (“consists of” the bile salt), consistent with the instant claims. The arguments regarding the preparation method are addressed above; the evidence of record does not demonstrate that the claimed product is distinguishable from amorphous associations known in the art made by a different process.
Regarding the nonstatutory double patenting rejection over copending Application No. 18/421,490, Applicant argues that the instant application has the earlier patent term filing date, and the rejection should be withdrawn according to MPEP 804.I.B.1(b)(i).
In response, the Examiner notes that MPEP 804 I.B. states, “A provisional double patenting rejection should be made and maintained by the examiner until the rejection has been obviated or is no longer applicable except as noted below”, and MPEP 804 I.B.1 (b)(i) states (emphasis added), “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent”. As detailed above, the provisional nonstatutory double patenting rejection is not the only rejection remaining, and thus the provisional nonstatutory rejection is not withdrawn at this time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
