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 .
Priority
The instant application was received 20 March 2024; it is a national stage application of PCT/CN2022/119826, filed 20 September 2022, and claims foreign priority to CN202111106864.8, filed 22 September 2021. Acknowledgment is made of Applicant’s claim for foreign priority and certified copies of the priority documents have been received.
Restriction/Election
Requirement for Restriction/Election was mailed 26 May 2026.
Applicant’s Response to Requirement for Restriction/Election was received 08 July 2026. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Applicant’s election of Group I (Claims 1-9 and 11-17) and
PNG
media_image1.png
138
154
media_image1.png
Greyscale
in the Response filed 08 July 2026 is acknowledged. Applicant’s request in the Response that the claims in Group II be considered for rejoinder should the claims of Group I be found allowable, and the non-elected species be reinstated, is acknowledged.
The claims in Group II (Claims 18-21) are withdrawn.
In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable.
Claims 1-9 and 11-17 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 18-21, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 26 May 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Status of the Claims
The listing of claims filed 20 March 2024 has been examined.
Claims 1-9 and 11-21 are pending.
Claims 4-5 and 8-9 are amended.
Claims 11-21 are newly added.
Claim 10 is cancelled.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 20 March 2024, 15 May 2025, and 07 November 2025 are acknowledged and have been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it uses phrases which can be implied, such as “The present application discloses…” and “Disclosed in the present application are…” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-3 and 6 are objected to because of the following informalities:
When reciting ranges, claims 1-2 use the tilde symbol (i.e., “~”). For example, claim 1 recites, “m is 1~6” (p. 3). Generally, a tilde symbol indicates a numerical approximation, like “~1” would mean “about 1.” For clarity, Examiner requests the tilde symbol be replaced by a dash symbol (i.e., “-“) in all instances where it appears within the instant claims.
Claim 1 recites, “…with at least one hydrogen atom is substituted by R 5-1…” [Emphasis added.] This appears to be a typographical error. Examiner suggests deleting “is” and deleting the unnecessary space between “R” and “5-1”.
Claims 1-2 recite, “..with at least one hydrogen substituted by R1-1, and phenyl with at least one hydrogen substituted by R1-1…” [Emphasis added.] For clarity, Examiner recommends changing “and” to “or”.
Claims 1-3 recite, “…C1~6 alkyl with at least one hydrogen substituted by R 1-1, phenyl with at least one hydrogen…” The word “or” appears to be missing between “R 1-1,” and “phenyl.”
Claim 6 recites, “…and/or, when R1 is methyl or ethyl and R1 is methyl or ethyl, R1 and R2 can be bonded to form a 5- to 6 -membered ring.” [Emphasis added.] This appears to be a typographical error, as it appears either the first or second instance of “R1” should be “R2”.
There are extra spaces between various words/characters throughout the instant claims. Removal of any unnecessary spaces is requested.
Appropriate correction is requested.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent-eligible subject matter because claims 18-21 recite a “use” of a product per se. “Use”-type claims are not considered to be statutory subject matter under US patent practice. “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101"). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967). See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112(a)
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-9 and 11-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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. The courts have stated that, “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 (Fed. Cir. 1997); In re Gostelli, 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 claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully 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 genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims of the instant application embrace, “A compound having a structure represented by general formula (I), or a pharmaceutically acceptable salt, stereoisomer, solvate or prodrug thereof…” (Claim 1). Particularly, the term “prodrug”, recited in claims 1-9 and 11-20, invokes the 35 U.S.C. 112(a) rejection. Even a cursory calculation of the number of compounds embraced in the instant claims would result in thousands of compounds.
Level of Skill & Knowledge in the Art
The level of skill and knowledge in the art is high.
Partial Structure
Compounds of formula (I) have been disclosed and example compound species that would be within the general formula have been disclosed. However, as to the claimed prodrugs, no specific examples have been given that would demonstrate possession or put the public in possession of all the claimed prodrugs of formula (I). It is generally accepted that prodrugs may vary by chemical formulae and may also differ in properties and the arrangement of atoms in the molecule.
Physical and/or Chemical Properties/Functional Characteristics
The compounds of formula (I), and prodrugs thereof, are compounds which are allegedly useful as mitophagy inducers. Although the art recognizes generally accepted definitions, the terms are not explicitly defined by the Specification in such a way as to demonstrate that the inventor had possession of the prodrug of formula (I).
A review of the prior art identifies Najjar (Najjar, A., & Karaman, R. (2019). Successes, failures, and future prospects of prodrugs and their clinical impact. Expert Opinion on Drug Discovery, 14(3), 199–220), which discloses successes and failures of prodrugs of known pharmaceuticals (Abstract; p. 212, Col. 2, 3. Previous failed prodrugs). Najjar teaches hetacillin, an ester prodrug of ampicillin, which was withdrawn since it did not have a superior advantage when compared to ampicillin. In light of Najjar, it is unknown which of the prodrugs of compounds of formula (I) claimed by Applicant will be active or inactive. Further, one of ordinary skill in the art would not be able to predict which compounds, of the vast number that are claimed, will be active or inactive absent evidence. There is no structure/function correlation in the Specification showing which prodrugs would or would not be active.
Since Applicant has not set forth compounds or substituents on formula (I) in the Specification which Applicant considers prodrugs, it is not clear what compounds fall under formula (I). Applicant has not described which prodrugs have the ability to function as mitophagy inducers, and which do not. Stated differently, there is no structure/function correlation and no representative number of specific examples of prodrugs that demonstrate which compounds retain activity. Further, one of ordinary skill in the art would not be able to predict the biological activity of the claimed prodrugs of formula (I).
Predictability of the Art
Medicinal chemistry is an experimental science with a low predictability level. Small changes in the structure of a compound can lead to large differences in their pharmacological activity. Regarding prodrugs, predicting if a certain claimed compound retains the activity and function of the original drug is filled with experimental uncertainty because prodrugs contain variation by chemical and physical properties of the molecules.
Method of Making the Claimed Invention
Although the Specification provides some exemplary methods for making compounds of formula (I), no method for making all of the compounds, including the prodrugs, encompassed by the instant claims has been disclosed. Methods of synthesizing compounds are, in general, known to a person of ordinary skill; however methods of making the myriad of compounds encompassed by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as prodrugs, are merely described partially.
As such, the instant Specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the prodrugs of formula (I) because the examples illustrated in the experimental section are limited to only compounds of formula (I).
Substantial and undue experimentation would be needed to practice Applicant’s invention because the Specification lacks sufficient detail to show how to use the prodrugs of the instant invention. Further, there is no guarantee that all of the prodrugs embraced by the scope of the claims would be useful as mitophagy inducers.
Even with the undue burden of experimentation, there is no guarantee that one would obtain the product of a desired prodrug of an instant compound of formula (I). Although some functional characteristics are disclosed or would be known to one of ordinary skill in the art, in the absence of a disclosed structure, there can be no correlation between the function and structure of the claimed prodrugs in the instant application.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. It is unquestionable that the claim(s) are broad and generic with respect to all possible compounds encompassed by the claims, as the possible structural variations are limitless to any prodrugs of the genus. In the instant case, however, the Specification does not disclose a sufficient variety of species to reflect this variance in the genus. The Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims, such as prodrugs of formula (I).
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.”) Accordingly, it is deemed that the Specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. This rejection would be overcome by amending the claims to remove the term “prodrug”.
Claim 21 fails to remedy this issue in claim 9 and, consequently, is included in this rejection.
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.
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.
Claims 8 and 18-21 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.
Regarding claim 8, several recited structures appear to be incomplete. Specifically, Compounds 16 (p. 12) and 25-26 (p.14) seem to span beyond the boxes, meaning some atoms and/or bonds are not shown, thereby rendering this claim indefinite. For example, Compounds 25-26 (p. 14), shown below, appear incomplete:
PNG
media_image2.png
352
346
media_image2.png
Greyscale
Examiner requests Applicant amend to ensure all structures recited by claim 8 are shown in their entirety.
Claims 18-21 recite “use” of a product. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP 2173.05(q). Accordingly, the instant “use” claims are indefinite because the claims recite use of a product without setting forth any active steps defining how the use is practiced, leaving the metes and bounds of the claim unclear.
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.
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 6 is 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.
Claim 6, which depends on claim 5, recites, “R1 is hydrogen, methyl, ethyl, cyclopropanyl or cyclobutanyl; and/or, R2 is hydrogen, methyl ethyl, phenyl, cyclopropyl, cyclobutanyl or 2-hydroxyethyl; and/or, when R1 is methyl or ethyl and R1 is methyl or ethyl, R1 and R2 can be bonded to form a 5- to 6 -membered ring.” [Emphasis added.] Claim 5, which depends on claim 1, recites X is nitrogen. However, claim 1 fails to indicate R2 can be hydrogen when X is nitrogen. Thus, claim 6 improperly expands the scope of claim 1 to include compounds wherein R2 is hydrogen when X is nitrogen.
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.
Claim 7, which depends on claim 6, is objected to for depending on a rejected claim without resolving its issues.
Art Made of Record but not Applied
Claims 1-9 and 11-17 contain allowable subject matter. None of the prior art of record nor a search in the pertinent art area teaches a compound having a structure represented by general formula (I), or a pharmaceutically acceptable salt, stereoisomer, solvate or prodrug meeting all the instantly recited structural requirements.
The following is a statement of reasons for the indicated of allowable subject matter:
A compound having a structure represented by general formula (I) is claimed:
PNG
media_image3.png
226
199
media_image3.png
Greyscale
The closest prior art is Nikolovska-Coleska (WO 2013/052943 A2; IDS dated 20 March 2024, Cite No. 1) and Lawrence (WO 2010/005534 A2; IDS dated 15 May 2025, Cite No. 1). Shown below is a compound disclosed by Nikolovska-Coleska (p. 22, Col. 2, Row 2) and Lawrence (p. 15, Compound 10c), respectively, which share some structural similarities to the instantly claimed compounds:
[AltContent: textbox (Lawrence)][AltContent: textbox (Nikolovska-Coleska)]
PNG
media_image4.png
156
202
media_image4.png
Greyscale
PNG
media_image5.png
126
125
media_image5.png
Greyscale
The instantly claimed compounds differ from Nikolovska-Coleska and Lawrence in the following respects:
In the instantly claimed compounds, “…when X is oxygen, a dotted line does not exist and R2 does not exist, R1 is C1~6 alkyl, three- to six-membered cycloalkyl, three- to six-membered epoxyalkyl, phenyl, C1~6 alkyl with at least one hydrogen substituted by R1-1, and phenyl with at least one hydrogen substituted by R1-1, wherein R1-1 is hydroxyl, halogen, amino or C1~6 alkoxy…” (Claim 1). Accordingly, R1 cannot be H when X is O. However, in the compounds disclosed by Nikolovska-Coleska and Lawrence, X is O, but R1 is H. While Lawrence indicates the group corresponding to R1 in the instantly claimed compounds, may be H or alkyl (Claim 9, p. 139, Line 7), Lawrence fails to disclose any exemplary compounds wherein R1 is alkyl.
Thus, while Nikolovska-Coleska’s and Lawrence’s compounds share some structural similarities with the instantly claimed compounds having a structure of instantly recited formula (I), a skilled artisan would not have been motivated to make the aforementioned changes as a whole to the structures which would have resulted in compounds having a structure represented by instantly recited formula (I).
Non-Statutory 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 1-9 and 11-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/994,467 and claims 1-11 of copending Application No. 19/167,040.
Application ‘467 claims “uses” of compounds, including instantly claimed compounds, such as I-47 (Claim 5, p. 18):
PNG
media_image6.png
131
146
media_image6.png
Greyscale
Application ‘467’s Compound I-47 is structurally identical to instantly claimed Compound 3 (Claim 8, p. 9).
Application ‘467 does not expressly claim a compound having a structure represented by general formula (I).
Application ‘040 claims “uses” of compounds, including instantly claimed compounds, such as I-45 (Claim 5, p. 17):
PNG
media_image7.png
141
156
media_image7.png
Greyscale
Application ‘040’s Compound I-45 is structurally identical to instantly claimed Compound 1 (Claim 8, p. 9).
Application ‘040 does not expressly claim a compound having a structure represented by general formula (I).
MPEP 804(II)(B)(1) states, “According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’ In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
The utility of the claims is disclosed by the Specification, therefore rendering the instant claims obvious. In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2024), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
Because claims 1-9 and 11-21 in the instant application would have been obvious over claims 1-14 of copending Application No. 18/994,467 and claims 1-11 of copending Application No. 19/167,040, claims 1-9 and 11-21 in the instant application are not patentably distinct from claims 1-14 of copending Application No. 18/994,467 and claims 1-11 of copending Application No. 19/167,040.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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, ADAM C MILLIGAN can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights