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 a 371 application filed -----3/16/2022, which is a national stage application of PCT/US2020/051590 filed 9/18/2020, which claims domestic priority to 62/902,782 filed 9/19/2019.
As filed, claims 1-13 and 15-21 are pending; and claim 14 is cancelled.
Election/Restrictions
Applicant’s election without traverse of Group I – Claims 1-11 in the reply filed on 6/8/2026 is acknowledged.
Claims 12, 13, and 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
Regarding the election of species requirement, Applicant, without traverse, elected the species of CGP 57380, which is found on pg. 17 of the instant specification. The claim, which read on the elected species, is instant claim 5, according to Applicant’s reply filed on 6/8/2026. However, the Examiner finds that claims 1-4 and 11 also read on the elected species. Accordingly, claims 1-5 and 11 will be examined herein.
Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 statement (IDS) submitted on 2/16/2023 has 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.
Claims 3 and 4 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 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 3 recites the limitation, “an inhibitor of MNK1/2”, and claim 4 recites the limitation, “an MNK1, MNK2, or pan-MNK inhibitor”, in reference to the instantly claimed process. Applicant has not described the claimed genus of “an inhibitor of MNK1/2” or “an MNK1, MNK2, or pan-MNK inhibitor” 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 “inhibitor of MNK1/2” or “MNK1, MNK2, or pan-MNK inhibitor” encompasses any known and unknown molecule (e.g. compound, siRNA, antibody, etc.) that have inhibitory activity toward MNK1, MNK2, or both. Applicants described CGP-57380, timovosertib, ETC-206, SLV-2436, and cercosporamide as examples of “inhibitor of MNK1/2” or “MNK1, MNK2, or pan-MNK inhibitor” (see below), 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 “inhibitor of MNK1/2” or “MNK1, MNK2, or pan-MNK inhibitor”. As such, the claims lack adequate written description for the claimed ““inhibitor of MNK1/2” or “MNK1, MNK2, or pan-MNK inhibitor”.
PNG
media_image1.png
314
732
media_image1.png
Greyscale
(pg. 17, lines 1-9 of the instant specification)
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 1, 2, and 11 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 1, the claim recites the following:
PNG
media_image2.png
86
594
media_image2.png
Greyscale
It is unclear to the Examiner how the level of FICDs is reduced in the subject. As a result, the claim does not stand alone, and one must refer back to the specification to define the claimed invention to determine the metes and bounds of the claim. Thus, the claim is rendered indefinite.
Regarding claims 2 and 11, the claims are dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered these claims indefinite.
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.
Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by “Calpain is Required for Normal Osteoclast Function and Is Down-regulated by Calcitonin”, hereinafter Marzia.
Regarding claims 1 and 11, Marzia, for instance, teaches that calcitonin (CT) inhibits osteoclast bone resorbing activity in part by down-regulating (i.e. inhibiting) calpain activity. Like CT, calpain inhibitors, such as calpeptin and MDL28170, have also shown to reduce osteoclast bone resorbing activity. All of which suggest the abovementioned inhibition or reduction resulted in slower progression of osteopenia, which lead to the anticipation of the instant process.
Although Marzia did not explicitly teach CT or the calpain inhibitors reduce the level of FICDs, the Examiner finds that the reduction in the levels of FICDs is an inherent feature of CT or the calpain inhibitors. According to MPEP 2112(I) and (II), the discovery of a previously unappreciated feature of CT or calpain inhibitors does not render the abovementioned reduction of the FICDs level patentable to Applicant. In addition, such inherent feature did not have to be recognized at the time of the invention by Marzia.
PNG
media_image3.png
222
1134
media_image3.png
Greyscale
(pg. 2, last paragraph)
PNG
media_image4.png
642
1252
media_image4.png
Greyscale
(abstract)
PNG
media_image5.png
108
1124
media_image5.png
Greyscale
(pg. 5, last paragraph)
PNG
media_image6.png
300
1142
media_image6.png
Greyscale
(pg. 6, 4th paragraph)
PNG
media_image7.png
356
1116
media_image7.png
Greyscale
(pg. 6, 5th paragraph)
PNG
media_image8.png
108
1170
media_image8.png
Greyscale
(pg. 7, 1st paragraph)
PNG
media_image9.png
510
1152
media_image9.png
Greyscale
(pg. 10, 3rd paragraph)
PNG
media_image10.png
320
1132
media_image10.png
Greyscale
(pg. 8, 3rd paeragrpah)
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, the claim recites the phrase, “reducing the level of FMS intracellular fragments (FICDs) in the subject”.
Such expression can be clarified by reciting -- reducing level in the subject --.
Appropriate correction is required.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-4 and 11 are rejected.
Claims 1 and 5 are objected.
Claims 6-10, 12, 13, and 15-21 are withdrawn.
Claim 14 is 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.
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, 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.
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.
/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
Prosecution Insights