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 .
This is the first action on the merits.
Claims 1 and 4-15 are pending and under examination.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) (PROVISIONAL) or 119(a) (FOREIGN) or under 35 U.S.C. 120 (CONT/CIP), 121(DIV), or 365(c) (WO) is acknowledged. Applicant still has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) (PROVISIONAL) as follows: The later-filed application must be an application for a patent application (the parent for an invention which is also disclosed in the prior application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 63159338, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for claims 1-7, 11, 12 and 14 of this application. The present formula I is not found in the priority provisional document because the n and R1 variables are broader than what is disclosed in the provisional document. There may be other omissions as well. Thus, the effective filing date of the present claims 1-7, 11, 12 and 14 is the immediate filing date of March 9, 2022. The effective filing date of claims 8-10, 13 and 15 is March 10, 2021.
Drawings
The drawings are objected to because some are too blurry and cannot be read, e.g. 2A, 6A and 6D. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. A amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 8-15 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 pre-AIA the applicant regards as the invention.
Claims 1 and 15 are drawn to the treatment of diseases. The term “treatment” is defined on page 8 of the specification, which does not embrace prevention; and the phrase “treating a disease” is defined on page 9, which embraces prevention. Which definition is being claimed in claims 1 and 15? It’s unclear what the difference is between the term “treatment” and the phrase “treating a disease.” Thus, claims 1 and 8-15 are vague.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 and 8-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of hyperparathyroidism, osteoporosis or cancer cachexia, does not reasonably provide enablement for the prevention of hyperparathyroidism, osteoporosis or cancer cachexia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The term “treatment” is defined on page 8 of the specification, which does not embrace prevention; and the phrase “treating a disease” is defined on page 9, which embraces prevention.
It is presumed “prevention” of the claimed disease would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
The factors to be considered in making an enablement rejection were summarized above. 1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before the prostate cancer occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) On pages 8 and 9 of the specification defines treating a disease as prevention, see also the 112(b) rejection above. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical pharmacology and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will suffer from hyperparathryroidism, osteoporosis, or cancer cachexia before the fact. 6) The artisan using Applicants invention would be a Board-Certified physician with an MD degree. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of hyperparathryroidism, osteoporosis, or cancer cachexia. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent hyperparathryroidism, osteoporosis, or cancer cachexia. That is, the skill is so low that no compound effective generally against the prevention of hyperparathryroidism, osteoporosis, or cancer cachexia. 7) It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved" and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases.
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 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.
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ren et al. (WO 2010053548, cited on the IDS).
The reference teaches treating hyperparathyroidism and osteoporosis with a negative allosteric modulator of parathyroid hormone (PTH) type 1 receptor (PTHR), see abstract.
Therefore, claim 15 is anticipated.
Claim(s) 1, 4-7, 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sutkeviciute et al. (WO 2010053548, cited on the IDS with a December 21, 2021 published date).
The reference teaches the following species:
PNG
media_image1.png
214
264
media_image1.png
Greyscale
, see page 275, and “[w]hen tested [in vivo], Pitt12 caused a significant reduction in the effects of PTH on serum Ca2+ and Pi levels in mice, showing that Pitt12 can act as a negative modulator of PTHR function [in vivo] for as an allosteric modulator of PTHR. These small molecules are suitable lead compounds for further optimization and development into potential drug candidates for treatment of hyperparathyroidism, see page 279 first paragraph in the left column.
Claims 4-7 and 15 are fully or partially drawn to modes of action or properties of the compound shown above. These would occur inherently upon administration of said compound.
The priority provisional document cannot be relied on to overcome the present rejection since the claims are broader than what is found in the provisional document, see the priority section above.
Thus, claims 1, 4-7, 11 and 12 are anticipated.
Claim(s) 1, 4-7, 12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Feldman et al. (WO 9508534, cited on the IDS).
The reference teaches the following species:
PNG
media_image2.png
311
504
media_image2.png
Greyscale
, see page 82, lines 1-2, as a treatment for osteoporosis, see page 60, line 28.
Claims 4-7 and 15 are fully or partially drawn to modes of action or properties of the compound shown above. These would occur inherently upon administration of said compound.
Thus, claims 1, 4-7, 12 and 15 are anticipated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 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, Jeffrey Murray can be reached on 571-272-9023. 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.
/SUSANNA MOORE/Primary Examiner, Art Unit 1624