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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to amorphous nano-molecular associations, in the reply filed on 02/17/2026 is acknowledged.
Applicant’s further election of the species of a salt of an organic material, specifically the sodium salt of deoxycholic acid in the reply filed on 02/17/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election of species requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Claims 6, 8, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim; note that the nano-molecular association is interpreted as comprising the elected sodium salt of deoxycholic acid (see claim interpretation below) and thus claim 8 is withdrawn. Election was made without traverse in the reply filed on 02/17/2026.
Claims 1-5, 7, 9-13, and 15-16 are under current examination.
Priority
This application is a CIP of PCT/KR22/11132, filed 07/28/2022. Foreign priority has been claimed to KR10-2022-0093820, filed 07/28/2022, and KR10-2021-0099485, filed 07/28/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/26/2024, 02/20/2025, 04/28/2025, and 09/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities: on pg. 1, bottom paragraph, “to pss” is believed to be a typo of “to pass”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: “inorgasnic” in line 4 is believed to be a typo of “inorganic”; “organic material of a salt thereof” in line 4 is believed to be a typo of “organic material or a salt thereof”.
Claims 4 and 12 are objected to because of the following informalities: it is suggested that “1H NMR” should be formatted as “1H NMR”.
Claims 5 and 13 are objected to because of the following informalities: it is suggested that “cm-1” should be formatted as “cm-1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-5, 7, 9-13, and 15-16 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Independent claims 1 and 9 recite (emphasis added): “An amorphous nano-molecular association prepared by dissolving… wherein the organic material or a salt thereof or the inorganic material or a salt thereof is any one or more active pharmacological ingredients selected from the group consisting of 2’,7’-dichlorofluorescin diacetate (DCG-DA), niclosamide, ….and derivatives thereof.” Dependent claims 2-5, 7, 10-13, and 15-16 do not further limit the identity of the organic material or salt thereof or the inorganic material or salt thereof.
USDA (“Chemical Derivatives”, https://lod.nal.usda.gov/nalt/en/page/207583) defines chemical derivatives as “Compounds derived from a parent compound by a chemical reaction, and having similar chemical structure” (pg. 1, “Definition”). The instant claims are therefore drawn to the genus of an amorphous nano-molecular assembly prepared from any one or more of the numerous recited active pharmaceutical ingredients and compounds derived therefrom by a chemical reaction. However, the instant specification does not describe a representative number of species for the genus such that Applicant is in possession of the claimed genus.
To provide adequate written description and evidence of possession of a claimed genus, the
specification must provide sufficient distinguishing identifying characteristics of the genus. The factors
to be considered include disclosure of complete or partial structure, physical and/or chemical
properties, functional characteristics, structure/function correlation, methods of making the claimed
product, or any combination thereof.
In making a determination of whether the application complies with the written description
requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has
possession of and what Applicant is claiming. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention
and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor
invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41
USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir.
1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that
[the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that
which makes it obvious," and by using "such descriptive means as words, structures, figures,
diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41
USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has
been furnished in the disclosure of the Application. These include “level of skill and knowledge in the
art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled
with a known or disclosed correlation between structure and function, and the method of making the
claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the
claimed invention from other materials and would lead one of skill in the art to the conclusion that the
applicant was in possession of the claimed species is sufficient” (see MPEP 2163).
Further, for a broad generic claim, the specification must provide adequate written description
to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court
stated:
“A written description of an invention involving a chemical genus, like a description of a
chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical
name,’ of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984
F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85
(CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is
unpredictability in performance of certain species or subcombinations other than those
specifically enumerated, one skilled in the art may be found not to have been placed in
possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d
1398.
The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus; if the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus (see MPEP 2163). Although the MPEP does not define what constitute a sufficient number of representatives, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, regarding the genus of derivatives of the active pharmacological ingredients of claims 1 and 9, there are a nearly infinite number of possible derivatives of the recited active pharmaceutical ingredients. These derivatives would be expected have substantial variance in structure and properties, and may include derivatives discovered at a later date. The specification does not set forth a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus to every possible derivative of the active pharmaceutical ingredients, see Eli Lily, 119 F.3d at 1568, 43 USPQ2d. at 1406. The specification exemplifies the preparation of amorphous assemblies of sodium deoxycholate, sunitinib maleate, DCF-DA, and cyclosporin A, but no “derivatives” of the recited active pharmaceutical ingredients of claims 1 and 9.
The MPEP states a "representative number of species" means that the species which are
adequately described are representative of the entire genus. Here, the specification exemplifies a limited number of species of active pharmaceutical ingredients and no derivatives thereof, and therefore does not disclose a representative number of examples to cover the breadth of the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
As stated above, the MPEP states that a broad genus can be described by a showing of
representative number of examples. However, the claims are extremely broad, and the specification does not disclose a representative number of examples which encompass the breadth of the genus of derivatives of the active pharmaceutical ingredients of claims 1 and 9. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
Therefore, for the reasons presented above (with emphasis regarding a lack of representative
number of species), the instant claims lack written description.
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.
Claims 1-5, 7, 9-13, and 15-16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “close proximity” in claims 1 and 9 is a relative term which renders the claims indefinite. The term “close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The meaning of the limitations “the organic material or a salt thereof or the inorganic material or a salt thereof is physically bonded” in claim 1 and “salts of the organic material or the inorganic material is physically bonded” in claim 9 is unclear. It is unclear if this is intended to mean that a) molecules of the material or salt are bound to each other or b) molecules of the material or salt are bound to another material.
The meaning of the term “associated structure” in claims 1 and 9 is vague and unclear. The term is not defined in the specification and does not appear to be a term commonly used in the art. One of ordinary skill in the art would not understand what the metes and bounds of an “associated structure” are and would not be reasonably apprised of the scope of the invention.
The terms “travo” and “prost” in line 12 of claim 1 and line 10 of claim 9 are not terms known in the art as active pharmacological ingredients, and it is unclear what compounds these are intended to refer to.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 9, recite the broad recitation “vitamin A”, and the claim also recites “retinol” in parentheses which is the narrower statement of the range/limitation. As evidenced by Lindshield (“12.6: Vitamin A”, https://med.libretexts.org/Courses/Kansas_State_University/FNDH_400%3A_Human_Nutrition_(Lindshield)/12%3A_Blood_Bones_and_Teeth_Micronutrients/12.06%3A_Vitamin_A), there are 3 forms of vitamin A (retinol, retinal, and retinoic acid) (see pg. 1, paragraph 1).
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-5 and 7 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 1 and failure to cure the deficiencies noted above.
Claims 10-13 and 15-16 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 9 and failure to cure the deficiencies noted above.
Claims 2-5 and 10-13 recite the limitations “material itself” and “nano-molecular association itself”; the use of the term “itself” is unclear. Is this intended to mean the material/association in the absence of any other components such as solvents? If the association comprises the material, how is the “material itself” distinguished from the “association itself”?
Claims 2 and 10 recite the term “result values” in reference to characterization techniques of HPLC, NMR, and FT-IR. Each of these techniques produces multiple “values”: HPLC produces retention time and peak integration values; NMR produces chemical shift and peak integration values; FT-IR produces wavenumber and % transmittance values. Further, there are multiple types of NMR measurements that can be performed (different nuclei, 1D, 2D, etc.). It is unclear if the claims require that all or merely some of these “values” be the same/different. It is suggested that Applicant can incorporate the limitations of claims 3-5 into claim 2 and the limitations of 11-13 into claim 10 to more clearly define what is meant by “result values”.
Claims 7 and 15 recite “the nano-molecular association has an intermolecular distance of 10 Å or less”. This is indefinite as it is unclear what distance the “intermolecular distance” is referring to. Is this referring to the distance between molecules in a single amorphous nano-molecular assembly? The distance between particles of the nano-molecular association? Some other distance?
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—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.
Claims 3 and 11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 10, from which claims 3 and 11 depend, respectively, recite “have the same result values as measured by high-performance liquid chromatography”. Here, “the same” is interpreted to mean the values are identical.
Claims 3 and 11, respectively, recite “the result values measured by HPLC…are determined to be the same when they have a retention time within 10%” which broadens the scope of the limitation of “the same”, and thus the claims fail to further limit the subject matter of the claims upon which the depend.
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 complies with the statutory requirements. It is suggested that Applicant can incorporate the limitations of claims 3 and 11 into claims 2 and 10, respectively.
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 molecules of an organic material or a salt thereof or an inorganic material or a salt thereof in a solvent and bringing the molecules in close proximity to each other, in which the organic material of a salt thereof or the inorgasnic material or a salt thereof is physically bonded, wherein the nano-molecular association has an associated structure in the solvent…” and claim 9 recites (emphasis added) “An amorphous nano-molecular association prepared by dissolving salts of an organic material or an inorganic material in a solvent and bringing the molecules of the salts in close proximity to each other, in which salts of the organic material or the inorganic material is physically bonded, wherein the nano-molecular association has an associated structure in the solvent…”
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)”. Further, as noted above, the recited process recites limitations that render the scope of the claim indefinite.
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 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.
Claim 16 recites “the nano-molecular association is composed of the salt or organic material or inorganic material”. MPEP 2111.03 IV states, “The transitional phrase "composed of" has been interpreted in the same manner as either "consisting of" or "consisting essentially of," depending on the facts of the particular case. See AFG Industries, Inc. v. Cardinal IG Company, 239 F.3d 1239, 1245, 57 USPQ2d 1776, 1780-81 (Fed. Cir. 2001)”. As noted above, it is unclear if the material claimed is “physically bonded” to another material or not. Thus, the Examiner broadly interprets “composed of” as have the meaning “consists essentially of”. Per MPEP 2111.03 III., “The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original)” and “If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of "consisting essentially of," applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App. & Inter. 1989).”
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 1-5, 9-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2001/0024658 A1, published September 27th, 2001), hereafter “Chen”.
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]). 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]).
Regarding instant claim 16, as noted above, Chen teaches an amorphous bile salt of sodium deoxycholic acid and particle sizes consistent with those of the instant claims. It is interpreted that particles containing the amorphous salt of deoxycholic acid are “composed of” the salt.
Chen does not exemplify amorphous sodium deoxycholic acid with an average particle diameter of 50 nm or less with sufficient specificity to anticipate the instant claims, but rather renders them obvious. Chen teaches preferable particle sizes which overlap with the claimed range, rendering the range prima facie obvious to one of ordinary skill in the art. 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)”.
The limitations of claims 2-5 and 10-13 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; absent evidence to the contrary, the claimed measured properties will be present.
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)”.
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chen as applied to claims 1-5, 9-13, and 16 above, and further in view of Li et al. (“A Comparison of the Crystallization Inhibition Properties of Bile Salts” Cryst. Growth Des. 2016, 16, 7286-7300), hereafter “Li”.
The teachings of Chen are described above.
Chen does not explicitly teach that the nano-molecular association has an intermolecular distance of 10 Å or less.
Li teaches that bile salts are able to inhibit crystallization of poorly water-soluble compounds, contribute to the duration of supersaturated solutions, and may maintain the stability and performance attributes of amorphous solid dispersions (see entire document, particularly Abstract and Discussion); Li teaches that these bile salts include sodium deoxycholate, or SDC (the sodium salt of deoxycholic acid) (see particularly Tables 1 and 3-4; Figures 8, 10). Li teaches that van der Waals and hydrogen bonding occur (see particularly abstract, Figures 7-8, and their descriptions on pg. 7294-7295). Li defines hydrogen bond cut-offs of 3.0 Å and that molecules are considered part of the same cluster if the intermolecular distance was equal or less than 3.0 Å (pg. 7290, “Molecular Dynamics Simulations”).
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 taught by Chen would comprise molecules with an intermolecular distance of 3.0 Å or less, overlapping the claimed range, as suggested by Li. Li teaches that an intermolecular distance of 3.0 Å can be used to define the hydrogen bonding distance and distance of molecules considered to be in the same cluster in sodium deoxycholic acid compositions that inhibit crystallization and contribute to the stability of amorphous dispersions. Chen similarly teaches particles of amorphous sodium deoxycholic acid; from the teachings of Li, one of ordinary skill in the art would recognize that the sodium deoxycholic acid of Chen is able to undergo hydrogen bonding with intermolecular distances of 3.0 Å or less. Further, 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)”.
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 1-5, 7, 9-13, and 15-16 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 prepared by dissolving molecules of an organic material or an inorganic material in a solvent and bringing the molecules in close proximity to each other, in which the material is physically bound, wherein the nano-molecular association has an associated structure in the solvent. Both sets of claims recite that the material is sodium salt of deoxycholic acid, the same particle diameter, and the same intermolecular distances.
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 the same process, and 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.
Claims 1-5, 7, 9-13, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-5 of copending Application No. 18/578,902 (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 18/578,902 are directed to amorphous molecular associations of molecules of a salt of deoxycholic acid with an associated structure in a solvent. Both sets of claims recite overlapping particle diameters.
The claims of co-pending Application 18/578,902 do not recite the HPLC, NMR, or FT-IR result values of the instant claims or the instantly claimed intermolecular distances. However, both sets of claims recite the amorphous associations that are substantially identical and are made by substantially identical processes; absent evidence to the contrary, the associations claimed in co-pending Application 18/578,902 possess the same properties. 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.
Claims 1-5, 7, 9-13, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 8 of copending Application No. 18/579,262 (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 18/579,262 are directed to amorphous molecular associations of molecules of a salt of deoxycholic acid with an associated structure in a solvent. Both sets of claims recite overlapping particle diameters.
The claims of co-pending Application 18/579,262 do not recite the HPLC, NMR, or FT-IR result values of the instant claims or the instantly claimed intermolecular distances. However, both sets of claims recite the amorphous associations that are substantially identical and are made by substantially identical processes; absent evidence to the contrary, the associations claimed in co-pending Application 18/579,262 possess the same properties. 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.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611