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 . Claims included in prosecution are claims 1-8 and 14-17.
Restriction Requirement
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-8 and 14-17, drawn to a method for treating.
Group II, claim(s) 10-13, drawn to a method for producing a composition.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Herthel et al. (US 2017/0173093, Jun. 22, 2017) (hereinafter Herthel).
Herthel discloses a method of treating Clostridium difficile associated disease, or a symptom thereof, comprising the step of administering a composition comprising smectite (Ref. Claim 39).
In view of this document, the common technical feature linking Groups I-II does not constitute a special technical feature as defined by PCT Rule 13.2, as it does not define a contribution over prior art for the reasons set forth above.
During a telephone conversation with Hyunseok Park on 12/16/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8 and 14-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
1. Claims 3-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 & 4recite an “Na-type bentonite”, “Ca-type bentonite”, and/or “Mg-type bentonite”. The claim is indefinite because it is unclear how “type” modifies the otherwise definite terms “Na”, “Ca”, and/or “Mg”. Since the term “type” isn’t necessary for an understanding of the claimed subject matter, the examiner recommends deleting it.
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.
1. Claim(s) 1-2, 5-6, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herthel et al. (US 2017/0173093, Jun. 22, 2017) (hereinafter Herthel).
Herthel discloses are compositions useful for the treatment or prevention of Clostridium difficile associated disease in a subject where the compositions comprise an effective amount of smectite and, optionally, an effective amount of at least one second agent (or at least one
further agent) for the treatment or prevention of Clostridium difficile associated disease in a subject in need thereof (¶ [0002]). In another aspect, Herthel discloses methods of
treating or preventing C. difficile associated disease in a subject in need thereof where the methods comprise administering the aforementioned composition in an amount effective to treat or prevent the disease (satisfies method of claim 1) (¶ [0012]). In certain embodiments,
the smectite is in the form of bentonite (satisfies active of claim 1-2) (¶ [0019]). In certain embodiments, the composition can further comprise one or more pharmaceutical agents such as antibiotics. Suitable antibiotics include vancomycin (satisfies claim 5-6 and 14-15) (¶ [0057]). The prior art anticipates the indicated claims because it discloses methods of
treating or preventing C. difficile associated disease comprising administering smectite that is in the form of bentonite along with antibiotics such as vancomycin as instantly claimed.
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.
1. Claim(s) 7-8 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herthel et al. (US 2017/0173093, Jun. 22, 2017) (hereinafter Herthel).
Herthel discloses are compositions useful for the treatment or prevention of Clostridium difficile associated disease in a subject where the compositions comprise an effective amount of smectite and, optionally, an effective amount of at least one second agent (or at least one
further agent) for the treatment or prevention of Clostridium difficile associated disease in a subject in need thereof (¶ [0002]). In another aspect, Herthel discloses methods of
treating or preventing C. difficile associated disease in a subject in need thereof where the methods comprise administering the aforementioned composition in an amount effective to treat or prevent the disease (¶ [0012]). In certain embodiments, the smectite is in the form of bentonite (¶ [0019]). In certain embodiments, the composition comprises 1 mg to 50 g smectite (¶ [0033]). In certain embodiments, the composition can further comprise one or more pharmaceutical agents such as antibiotics. Suitable antibiotics include vancomycin (¶ [0057]).
Herthel differs from the instant claims insofar as not explicitly disclosing the ratios and dosages of bentonite and vancomycin recited in the instant claims.
However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, bentonite and vancomycin are active pharmaceutical ingredients, which makes ratios/dosages thereof a result effective variable, since ratios/dosages directly impact the therapeutic effect. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed ratios/dosages of bentonite and vancomycin to yield the desired therapeutic effect.
Therefore, the teachings of Herthel render obvious claims 7-8 and 16-17.
2. Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herthel et al. (US 2017/0173093, Jun. 22, 2017) (hereinafter Herthel) in view of Naik et al. (US 2017/0251674, Sep. 7, 2017) (hereinafter Naik).
The teachings of Herthel are discussed above.
Herthel differs from the instant claims insofar as not disclosing wherein the bentonite used is sodium bentonite.
However, Naik teaches a method of modulating the flora of bacteria in an environment comprising administering an effective amount of a quorum sensing control composition comprising at least one quorum sensing control agent such as phyllosilicate clays (Abstract). Diseases caused by drug-resistant Gram-negative bacteria, such as C. difficile, which exhibit resistance to current antibiotic treatments, could also be treated by administering effective amounts of an agent that inhibits or interferes with bacterial quorum sensing alone or in combination with antibiotics or other antibacterial agents to treat, for example, an animal,
whether it be a human or companion animal (¶ [0009]). Suitable clays include bentonites such as sodium bentonite (¶ [0054]). The quorum sensing control formulations may also include one or more antibiotics (¶ [0113]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, Herthel discloses wherein the composition may comprise bentonite. Accordingly, it would have been prima facie obvious for one of ordinary skill in the art to have formulated the composition of Herthel to comprise sodium bentonite, since it is a known bentonite for use in methods for treating diseases caused by bacteria such as C. difficile as taught by Naik.
Therefore, the combined teachings of Herthel and Naik render obvious claims 3-4.
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.
1. Claims 1-8 and 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,890,295 in view of Burnie et al. (US 2008/003826, Feb. 14, 2008) (hereinafter Burnie).
The instant claims and the patented claims both recite a clay mineral complex comprising smectite and antibiotics for treating a bacterial infection.
The patented claims differ from the instant claims in that they disclose specific antibiotics such as gentamicin and do not disclose treating C. difficile.
However, Burnie teaches compounds, medicaments and treatments for Clostridium difficile infection (Abstract). Gentamicin is utilized in the method of treatment of infection Clostridium difficile (¶ [0047]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have utilized the composition of the patented claims in the method of the instant claims since gentamicin is a known and effective antibiotic for use in method of treating Clostridium difficile infections as taught by Burnie.
Conclusion
Claims 1-8 and 14-17 are rejected.
Claims 10-13 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612