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 .
DETAIL ACTION
This office action is a response to the following:
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As filed, claims 16-18, 21-35, 37, and 38 are pending; and claims 1-15, 19, 20, and 36 are cancelled.
Election/Restrictions
Regarding the election of species requirement, Applicant, without traverse, elected the species of SBI-553, which has the structure of
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and can be found in Fig. 1 of the instant specification. The claims, which read on the elected species, are instant claims 16-18, 21-35, 37, and 38, according to Applicant’s reply filed on 3/20/2026.
Examination will begin with the elected species. In accordance with the 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. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. 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. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does not make a contribution over the prior art.
According to MPEP 803.02: should the elected species appear non-allowable, the search of the Markush-type claim will not be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 11/12/2023 and 7/12/2024 have been considered by the Examiner.
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.
Claim 16-18, 21-35, and 37 is 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 claim(s) 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16 recites the limitation, “neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity”, in reference to the instantly claimed process. Applicant has not described the claimed genus of “neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity” in a manner that would indicate they were in possession of the full scope of this genus, or even to describe what this genus is comprised of.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In the instant case, the claimed “neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity” encompasses any known and unknown molecule (e.g. compound, siRNA, antibody, etc.) that have functionally selective β-arrestin biased activity. Applicants described compound of instant formula (I) or (II) as examples of “neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity” (paragraphs 0089-0090), which are not described adequately enough to allow one skilled in the art to ascertain that Applicant is in possession of the entire scope of that genus. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the compounds contemplated for use.
The law recognizes the pharmaceutical art as an unpredictable art and requires each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970). Accordingly, the more unpredictable an area is the more specific disclosure is necessary in order to satisfy the statute. Section 2164.02 of the MPEP provides:
"[C]orrelation” as used herein refers to the relationship between in vitro and in
vivo animal model assays and a disclosed or a claimed method of use . . . if the
art is such that a particular model is recognized as correlating to a specific
condition, then it should be accepted as correlating unless the examiner has
evidence that the model does not correlate.
In light of these remarks, the Examiner finds that one of ordinary skill in the art would agree with the court; that is, the pharmaceutical art is unpredictable. Thus, a substantial correlation is necessary for the claimed “neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity”. As such, the claims lack adequate written description for the claimed “neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity”.
Regarding claims 17, 18, and 21-35, these claims are directly or indirectly dependent of claim 1, and they failed to correct the defective issue in claim 1, which rendered these claims improper.
Claim 37 recites the limitation, “derivative thereof”, in reference to the compound of instant formula (I) or (II). Applicant has not described the claimed genus of "derivative thereof" in a manner that would indicate they were in possession of the full scope of this genus, or even to describe what this genus is comprised of.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
In the instant case, the claimed "derivative thereof" encompasses the compound of instant formula (I) or (II) with a differing, limitless, and undefined variation quoted for the identical purpose. Applicants failed to provide any example of “derivative thereof”, in respect to the compound of instant formula (I) or (II), which are not described adequately enough to allow one skilled in the art to ascertain that Applicant is in possession of the entire scope of that genus. Applicants have not described this genus in a manner that would allow one skilled in the art to immediately envisage the derivative of the compound of instant formula (I) or (II) contemplated for use. As such, the claims lack adequate written description for the claimed “derivative thereof", in respect to the compound of instant formula (I) or (II).
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 16-18, 21-35, 37, and 38 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 16, the claim recites the phrase, “A method for treating and/or preventing pain in a subject”. The term, “and”, is interpreted by the Examiner that the pain is treated and prevented at the same time. Accordingly, it is unclear to the Examiner how a subject can be treated for pain, which means that the pain is present, while preventing the pain at the same time. With such ambiguity, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
Regarding claims 17, 18, 21-35, 37, and 38, the claims are directly or indirectly dependent of claim 16, and they failed to correct the indefiniteness issue of claim 16, which rendered these claims indefinite.
Regarding claim 34, the claim recites the phrase, “modifying an aspect of the method”. It is unclear to the Examiner what the abovementioned phrase is intending to encompass, especially which type of modification is being carried out to which part the instant method. With such ambiguity, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
Claim Interpretation
With regards to the phrases, such as “neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arresting biased activity" and “ligand does not elicit hypothermia, hypotension, and/or motor impairment in the subject” in claim 16; and “improving the subject’s ability to move and/or the subject’s level of mobility” in claim 27, the Examiner finds such phrases as simply stating inherent properties within the structure of instant formula (I) or (II), and the inherent features need not be recognized by the prior arts at the time of the invention. See MPEP 2111.02(II).
Accordingly, as the prior art teaches the instant compounds, the result would most necessarily to have functionally selective β-arresting biased activity or to not elicit hypothermia, hypotension, and/or motor impairment in the subject or to improve the subject’s ability to move and/or the subject’s level of mobility, specifically in the claimed compounds taught by the prior art (see rejection below).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16, 18, 21, 27-31, 37, and 38 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2017/0240514, hereinafter Pinkerton. See IDS filed 11/12/2023.
Regarding claims 16, 18, 21, 27-31, 37, and 38, Pinkerton, for instance, teaches the following compound or pharmaceutical composition thereof that modulate NTSR1, which can be used to treat (e.g. alleviate, etc.) acute or chronic pain or neuropathic pain. The following compound or pharmaceutical composition thereof is administered once or multiple times in one day. The following compound can also be administered in combination with opiate (e.g. methadone) or NSAID. The following compound and the opiate/NSAID can both be administered to the patient simultaneously, concurrently or sequentially. The dose of the following compound ranges from about 1 mg to about 1000 mg per day. All of which meet all the limitations of these claims.
In addition, the Examiner finds that a person of ordinary skill in the art would read the following disclosures of Pinkerton and “at once envisage” the claimed arrangement or combination in the abovementioned claims, which led to the abovementioned anticipation.
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(paragraph 0002)
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(paragraph 0166)
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(paragraph 0191)
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(paragraph 0589)
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(paragraph 0600)
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(paragraph 0595)
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(paragraph 0560)
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(paragraph 0170)
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(paragraph 0562)
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(example 15, pg. 194)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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 17 and 32-35 are rejected under 35 U.S.C. 103 as being obvious over Pinkerton.
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 17 and 32-35:
Determining the scope and contents of the prior art:
Pinkerton, for instance, teaches the abovementioned process of treating acute or chronic pain or neuropathic pain.
Ascertaining of the difference between the prior art and the claim at issue:
Pinkerton, for instance, did not explicitly teach the following:
therapeutically effective amount of the abovementioned compound comprises a dose of 1 mg/kg/day to about 100 mg/kg/day;
repeating the administering of the opiate/NSAID;
monitoring the subject for adverse effect; and
modify the method by changing the amount of the abovementioned combination, etc., when the adverse effect is present.
Finding of prima facie obviousness --- rationale and motivation:
The Examiner does not find the abovementioned deficiencies as result-effective variables because the Applicant fails to demonstrate these parameters to impart any unexpected or novel aspect to the instant method (i.e. no comparative example). “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, these parameters are viewed as routine optimization to optimize the instant process, and not a patentable distinction.
In addition, the Examiner finds that it would be prima facie obvious for a person of ordinary skill in the art (e.g. medical clinician) to repeat the administration of the opiate/NSAID, to monitor the subject for adverse effect, and/or to modify the treatment, such as changing the amount of the abovementioned combination, when adverse effect is observed, in order to optimize the method of Pinkerton so that the pain of the patient can be alleviated in the shortest amount of time without having any adverse effect from the treatment.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to method of treating and/or preventing pain via a composition comprising a NTSR1 ligand having functionally selective β-arrestin biased activity.
Claims 16-18, 21, 27-35, 37, and 38 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
10,118,902
1-21
No
11,261,164
1-20
No
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned U.S. patents are drawn to a neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity.
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned U.S. patents described neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity in a Markush structure, and not in a method of treating pain-type claim.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness - none
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other because they are drawn to the same compound having the same therapeutic utility (e.g. NTSR1 ligand having functionally selective β-arrestin biased activity). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned U.S. patents.
As recited above, the compounds in the conflicting claims of abovementioned U.S. patents are the instant neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity. However, these conflicting claims described the NTSR1 ligand having functionally selective β-arrestin biased activity in a Markush structure, and not in a method of treating pain-type claim.
Structural similarity is the touchstone of the nonobviousness inquiry for patents claiming a novel chemical compound. Eisai Co. v. Dr. Reddy's Laboratories, 533 F.3d1353,1356-57 (Fed. Cir. 2008). In this case, the compounds are the same; i.e., they have the same atomic composition and the same atomic connectivity. For this reason, one of ordinary skill in the art would anticipate that this is the same compound.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that the structure of the abovementioned U.S. patents is excluded as the instant neurotensin receptor 1 (NTSR1) ligand having functionally selective β-arrestin biased activity of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant compound forms and that of the conflicting claims of the abovementioned U.S. patents to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy 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.
Claim Objections
Claims 29 and 35 are objected to because of the following informalities:
Regarding claim 29, the claim recites the phrase, “after the administration of the composition or the pharmaceutical formulation”.
Such expression can be clarified by reciting -- after the administration of the composition or the pharmaceutical formulation thereof --.
Regarding claim 35, the claim recites the phrase, “changing the frequency of administration of the composition, the pharmaceutical formulation”.
Such expression can be clarified by reciting -- changing thereof --.
Appropriate correction is required.
Conclusion
Claims 16-18, 21-35, 37, and 38 are rejected.
Claims 29 and 35 are objected.
Claims 1-15, 19, 20, and 36 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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