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 .
Claim Status
Claims 4 and 13 are cancelled.
Claims 1-3, 5-12 and 14-20 are pending.
Claims 10-12 and 14-20 are withdrawn.
Claims 1-3 and 5-9 are under examination. Applicants’ amendments have necessitated new ground of rejection. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicants’ amendments and arguments filed 9/9/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-3 and 5-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicants’ amendment is persuasive.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 2-3 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. As stated previously, claim 2 broadens the scope of claim 1, which is closed two-dimensional Mxene particles having one or more layers. Claim 2 still recites comprises and even though amended claim 1 now has at least one modification or termination “T” present on a surface of the layer body, in which each "T" is selected from the group consisting of a hydroxyl group, a fluorine atom, a chlorine atom, an oxygen atom, and a hydrogen atom, the modifications or terminations recited in claim 2 are outside the scope of claim 1. Dependent claim 3 is also rejected as being indefinite because it is dependent upon an indefinite claim and it also recites “comprises” and recites components outside the scope of amended claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments:
Applicant states: “Claim 2 has been amended to delete the clause identified by the Examiner as an alleged basis for indefiniteness. The Examiner did not identify any perceived issue(s) regarding the remaining claim language.” However, amended claim 1 now has at least one modification or termination “T” present on a surface of the layer body, in which each "T" is selected from the group consisting of a hydroxyl group, a fluorine atom, a chlorine atom, an oxygen atom, and a hydrogen atom, the modifications or terminations recited in claim 2 are outside the scope of amended claim 1 because they do not further limit the modifications/terminations present on a surface of the layer body recited in amended claim 1. Applicant’s argument Is not persuasive.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3 and 5-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou et al. (Theranostics 2022, Vol. 12, Issue 8: 3834-3846) as evidenced by Huang et al. (Nanophotonics 2020; 9(8): 2233–2249).
Regarding claims 1-3 and 5, Hou et al. discloses: “The PVP-modified Ti3C2 NSs exhibited excellent dispersity and long-term colloidal stability without significant dimensional change in H2O, phosphate-buffered saline (PBS), and Dulbecco’s Modified Eagle Medium (DMEM) (Figure 1L, Figure S4).” (Page 3836, left column). Solid particles, hence powder, of PVP-modified Ti3C2 NSs are shown in Figures 1A, 1E and 1F. It is the Examiner’s position that Ti3C2 meets the structural limitations of claims 2-3 and since the instant claims allow for at least one modification on a surface of the layer body and PVP is a pharmaceutically acceptable additive, then a pharmaceutical composition comprising MXene and PVP surface layer modification makes a solid particulate oral dosage form where the MXene consists of two-dimensional particles having one or more layers is disclosed by Hou et al. The instant specification teaches that powders are an example of dosage form [0090].
Regarding the limitations of “wherein the MXene is present in an amount effective for improving intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo in a human subject” and where the short chain fatty acids comprise butyric acid such is inherent in the pharmaceutical composition of Hou et al. Additionally, since no amount is claimed than any amount can be effective for the claimed intended uses.
Further regarding claim 1, the MXene of Hou et al. also appears to inherently comprises modifications on the surface of the layer body as evidenced by Huang et al. teaching: “the surface of MXenes is occupied by abundant hydrophilic groups such as fluorine (F), hydroxyl (OH), and oxygen (O), which endow MXenes with highly hydrophilic properties.” (Page 2233, Introduction right column).
Regarding claims 6 and 9, the limitation of “wherein the MXene is present in an amount effective to cause an increase in the amount or concentration of the one or more short-chain fatty acids in vivo in the human subject” that comprises butyric acid is inherent in the pharmaceutical composition of Hou et al.
Regarding claims 7-8, the identity of the intestinal bacterial flora, which is part of the intended use of the pharmaceutical composition, and the improvement comprises an increase in proliferation of the bacteria has been considered but is immaterial to the examination of a composition of matter claim and given no patentable weight. Any increase in bacterial proliferation is inherent in the composition.
Response to Arguments:
Applicant asserts that the rejection is based upon a mischaracterization of claim 1 and Hou does not disclose a modification or termination (T) listed within the Markush group and as a result the rejection is improper. Applicant’s arguments have been carefully considered but are not persuasive. Claim 1 recites that the “Mxene comprises Ti” and thus allows for other components such as PVP. And, as stated above, “the MXene of Hou et al. also appears to inherently comprises modifications on the surface of the layer body as evidenced by Huang et al. teaching: “the surface of MXenes is occupied by abundant hydrophilic groups such as fluorine (F), hydroxyl (OH), and oxygen (O), which endow MXenes with highly hydrophilic properties.” (Page 2233, Introduction right column).” Applicants’ arguments are not persuasive.
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 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 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 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Azushima et al. (WO2023204278 (published October 26, 2023; IDS foreign patent reference #3)).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical formulation research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from conventional pharmaceutical formulation components and dosage forms without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-3 and 5-9, Azushima et al. teach: “A pharmaceutical composition which comprises two-dimensional particles having one or more layers which include a layer body represented by the formula MmXn (in the formula, M is at least one type of metal belonging to group 3, 4, 5, 6, or 7, X is a carbon atom, a nitrogen atom, or a combination thereof, n is 1-4, inclusive, and m is greater than n and at most 5), and a modification or terminal T (T is at least one group or atom selected from the group consisting of a hydroxyl group, a fluorine atom, a chlorine atom, an oxygen atom, and a hydrogen atom) present on the surface of the layer body, said pharmaceutical composition being configured so as to be administered orally and as a result, adsorb disease-causing substances inside the organism.” (Abstract; claims 1-6). Titanium is a Group 4 metal. Thus, the MXene of Azushima et al. consists of two-dimensional particles having one or more layers comprising titanium as claimed. Azushima et al. teach that the pharmaceutical composition according to the embodiments can be made into various dosage forms such as tablets, capsules, liquids, injections, etc…with excipients also to be administered orally [0072-0074]. Azushima et al. teach: “When the pharmaceutical composition of the present disclosure is used for treatment, the dosage of the two-dimensional particles, which are its active ingredients, is appropriately determined depending on the age, sex, weight, disease, degree of treatment, etc. of the patient. For example, in the case of oral administration, the effective dose ranges from approximately 100 mg to 10 g/body per day for an adult (assuming a body weight of 60 kg), and may be administered once or in several divided doses as appropriate.” [0075]
Azushima et al. teach that the orally administered pharmaceutical composition absorbs disease-causing substance (Abstract) and methods of treating inflammatory bowel disease are disclosed (Claims 11-12). Additionally, since no amount is claimed, then any amount can be effective for the claimed intended uses.
Regarding claims 1 and 5, Azushima et al. teach Ti3C2 [0026 produced from “MAX phase”; Example 8, 0097-0100]. The species of MXene Ti3C2 must inherently have the claimed functional properties for improving intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo in a human subject.
Regarding claims 6 and 9, the limitation of “wherein the MXene is present in an amount effective to cause an increase in the amount or concentration of the one or more short-chain fatty acids in vivo in the human subject” that comprises butyric acid is implicit and flows naturally from administration of the pharmaceutical composition of Azushima et al. that administers the same structural MXenes such as Ti3C2.
Regarding claims 7-8, the identity of the intestinal bacterial flora, which is part of the intended use of the pharmaceutical composition, and the improvement comprises an increase in proliferation of the bacteria has been considered but is immaterial to the examination of a composition of matter claim and given no patentable weight. Any increase in bacterial proliferation is inherent in the composition.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Azushima et al. is that Azushima et al. do not expressly teach formulation of a solid oral dosage form wherein the MXene is present in an amount effective for improving intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo in a human subject. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the pharmaceutical dosage form of Azushima et al. as a solid oral dosage form and administer it to a human subject in an effective amount to improve intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Azushima et al. teach solid oral dosage forms such as tablets and that in the case of oral administration, the effective dose ranges from approximately 100 mg to 10 g/body per day for an adult (assuming a body weight of 60 kg), and may be administered once or in several divided doses as appropriate [0075] as well as the species of MXene Ti3C2. The instant specification teaches MXene amounts of from 1-100 mg administered 1-5 times daily [0088]. Consequently, the dosage amount overlaps, and the same active agent administered in the same amounts will implicitly improve intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Id. It does not matter if Azushima et al. recognized the inherent properties of Ti3C2. See MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).”
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments: Applicant asserts that 37 CFR 130(a)(2) does not say anything about a requirement to explain what was contributed by the other inventors. However, the defect in the Declaration was raised during the pre-appeal conference by the panel and stated in the non-FINAL filed 4/9/26. The Examiner cited MPEP 717.01(a)(1) for guidance. MPEP 717.01(a)(1) states: “(1) Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary.” Applicant has not provided a reasonable explanation of the presence of additional authors. Applicants citation of Ex Parte Katzman is noted but not relevant because the Examiner is not relying upon MPEP 717.01(b)(1)(B)(1-4). On page 10 of remarks, Applicant cites the passage (“scenario 1”) relied upon by the Examiner and asserts that: “There is absolutely no "evidence to the contrary" in the record providing any reason to doubt the declarant' s statement. As such, the present facts are aligned with scenario (1) set forth in the MPEP.” However, a reasonable explanation of the presence of additional authors is missing. Applicants’ arguments have been considered but are not persuasive.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (CN112089839 with English translation) as evidenced by Huang et al. (Nanophotonics 2020; 9(8): 2233–2249).
Regarding claims 1-3 and 5, Xu et al. teach a medicine for treating cancer comprising MXene (Claim 1) that is Ti3C2 (Claim 3) and any one or combination of more of pharmaceutically acceptable medical “accessories” (Claim 5). Xu et al. teach that MXene is a typical carbon-based two-dimensional material (Page 3, 2nd paragraph; Figure 3). The term “accessories” is interpreted to mean auxiliary materials because Xu et al. disclose the dosage form as a tablet, capsule, suspension, injection and comprises one or more pharmaceutically acceptable auxiliary materials such as excipients (page 3, bottom). A tablet is a solid dosage form. Thus, Xu et al. teach a pharmaceutical composition comprising MXene Ti3C2 and one or more pharmaceutical excipients in the form of a solid oral dosage tablet. It is the Examiner’s position that Ti3C2 meets the structural limitations of claims 2-3.
Regarding the limitations of “wherein the MXene is present in an amount effective for improving intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo in a human subject” and where the short chain fatty acids comprise butyric acid such is inherent in the pharmaceutical composition of Xu et al. Additionally, since no amount is claimed than any amount can be effective for the claimed intended uses.
Further regarding claim 1, the MXene of Xu et al. appears to inherently comprises modifications on the surface of the layer body as evidenced by Huang et al. teaching: “the surface of MXenes is occupied by abundant hydrophilic groups such as fluorine (F), hydroxyl (OH), and oxygen (O), which endow MXenes with highly hydrophilic properties.” (Page 2233, Introduction right column).
Regarding claims 6 and 9, the limitation of “wherein the MXene is present in an amount effective to cause an increase in the amount or concentration of the one or more short-chain fatty acids in vivo in the human subject” that comprises butyric acid is inherent in the pharmaceutical composition of Xu et al.
Regarding claims 7-8, the identity of the intestinal bacterial flora, which is part of the intended use of the pharmaceutical composition, and the improvement comprises an increase in proliferation of the bacteria has been considered but is immaterial to the examination of a composition of matter claim and given no patentable weight. Any increase in bacterial proliferation is inherent in the composition.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Xu et al. is that Xu et al. do not expressly teach in one embodiment a pharmaceutical composition formulated as a solid dosage form where the MXene consists of two-dimensional particles having one or more layers wherein the MXene is present in an amount effective for improving intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo in a human subject. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manufacture the pharmaceutical dosage form of Xu et al. where the MXene consists of two-dimensional particles having one or more layers as a solid oral dosage form and administer it to a human subject in an effective amount to improve intestinal bacterial flora in vivo or increasing an amount or concentration of one or more short-chain fatty acids in vivo, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following rationales. First, the structure of the MXene of Xu et al. does consist of two-dimensional particles having one or more layers with surface modifications. The limitation of “consists of two-dimensional particles having one or more layers” does not appear to exclude components such as Dox-Exjade loaded on the MXene. The limitation appears to exclude particles that are not two-dimensional having one or more layers. Secondly, in an alternative interpretation of the art, the ordinary artisan would formulate the MXene of Xu et al. without drug loading for use in comparative testing with a reasonable expectation of success. Regarding, the functional limitations of the claimed subject matter, such is inherent in the MXene pharmaceutical composition of Xu et al. See the discussion above which is incorporated by reference.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments: Applicant’s arguments filed 9/9/26 have been carefully considered but are not persuasive.
On page 11 of remarks, Applicant argues that the Dox-Exjade loaded particles of Xu are outside the scope of the present claims. However, Applicant has not rebutted the Examiner’s contention that the pharmaceutical composition is comprising and open to the inclusion of other components which can include active agents such as Dox-Exjade as long as the Mxene consists of two-dimensional particles having one or more layers as claimed and the rejection is over the obvious embodiment of particles without Dox-Exjade as explained above. Furthermore, the limitation of “wherein the Mxene comprises Ti” would also appear to allow the inclusion of other components beyond Ti such as an active agent including Dox-Exjade. The Examiner has provided a sound rationale as to why the ordinary artisan would be motivated to prepare particles without Dox-Exjade. Applicant respectfully disagrees with the Examiner's assertion that a person of ordinary skill in the art ("POSA") would conduct a hypothesized comparative study using compounds lacking the active (drug) moiety. In a pre-clinical (e.g., animal) or clinical (e.g., human drug trial) study, the typical experimental setup would include a control group receiving a placebo or no treatment, and one or more experimental groups receiving the drug of interest. There is no reasonable basis to suggest that a POSA would remove part of Xu's compound to test the remaining portion as a standalone compound. That is not an appropriate control.” The Examiner refers Applicant to 21 CFR 314.125 which requires adequate and well-controlled studies: “The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences”; and “The test drug is compared with an inactive preparation designed to resemble the test drug as far as possible.” (Page 1 of 3 seconds (a) and (b)(2)(i)). It is well-known in the pharmaceutical art to employ a vehicle control to “determine whether the vehicle alone causes any effects.” (Page 204, Vehicle Control in: Johnson et al. (ILAR J 2002;43(4):202-6)). Accordingly, testing the vehicle alone is well-known in the art. Applicants’ arguments are without merit.
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 1-3 and 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18919892. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending is directed to methods of administering an MXene adsorbent material as in claim 1:
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The copending does not expressly teach the instantly claimed intended uses but such are inherent in administering an effective amount of the co-pending adsorbent material.
The copending does not expressly teach Ti3C2 or as a solid oral dosage form and one or more pharmaceutically acceptable additives. However, the ordinary artisan can readily derive Ti3C2 from the copending claims 1 and 3 and oral administration of a solid oral dosage form with additives is within the scope of the claimed subject matter. Because the scope of the claimed subject matter includes dosage forms such as tablets [0102] and pharmacologically acceptable additives [0103]. See MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”
Regarding claims 6-9, the limitation of “wherein the MXene is present in an amount effective to cause an increase in the amount or concentration of the one or more short-chain fatty acids in vivo in the human subject” and comprise butyric acid and the identity of the intestinal bacterial flora and any improvements are inherent in the copending.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments: Applicant asserts that claim 1 in US18919892 does not recite a “solid oral dosage form” and it is improper to import elements from the specification when formulating a double patenting rejection. Respectfully, the Examiner does not agree. The claims in the copending disclose “particles” and “a layer body”, which describe a solid, and the intended use of being formulated as an oral dosage form is inherent in the copending particles and within the scope of the claimed subject matter. The Examiner did not use the specification to define terms but rather to properly construe the scope of the claims. Applicants’ arguments are not persuasive.
Conclusion
No claims are allowed.
Applicants’ 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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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