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 .
Claims 2-40 have been canceled.
Claims 1, 41-59 are pending and under examination.
Claim Objections
Claims 1, 42, 44, 46, 48 are objected to because of the following informalities:
Claim 1, please provide full name of “RANKL”.
Claim 42, line 2, “insufficiency”, please remove the last [“ ].
Claim 44, please provide full name of PTH, PTHRP, 25PHD, 1.25OH2D3, 24,25 OH2D3, TNF, FSH, LH, SIK.
Claim 46, please provide full name of hCG.
Claim 48, line 8, “insufficiency”, please remove the last [“ ].
Claim 48, last line, please provide full name of AMH.
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, 42, 44-47, 49-57 and 59 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.
As to claim 1, it is noted that the last option therapeutic to treat and/or improve fertility in a female by using “an inhibitor of RANKL”. Option #1 is use of a stimulator of RANKL, whereas option #5 is use of an inhibitor of RANKL. These two stimulator and inhibitor of RANKL are functionally distinct. In view of specification, however, the treatment of using inhibitor of RANKL is contrary to the results of applicant’ clinical studies. Section 0348, applicant state “Comparing women having an infertility diagnosis with those who were gynecological healthy, but with an infertile spouse, showed that the healthy women had significantly higher follicular RANKL levels (p=0.008, Man-Whitney U), but comparable levels of follicular OPG and comparable remaining follicular hormones and serum hormones (FIG. 11A-B)”. Moreover, section 0349 continues states “[0349] Clinical pregnancies obtained after ICSI and IVF resulting in live birth showed that woman who gave birth had borderline significantly higher serum RANKL, compared to those who became pregnant but had an early spontaneous abortion (p=0.054 Man-Whitney U, FIG. 12A). This shows that high RANKL is linked with successful pregnancy outcome and not just pregnancies. Furthermore, woman who became pregnant after IVF or ICSI and progressed to week seven with a positive fetal heartbeat, verified by ultrasonography, had significantly higher serum RANKL than those who became pregnant but didn't progress to week seven (p=0.012 Man-Whitney U, FIG. 12B).
Taken together, the goal is to increase the level of RANKL, not to diminish or lower the level of RANKL. Thus the inhibitor of RANKL would play a role in downregulating RANKL which would lead to an adverse effect on fertility. Please clarify.
Similarly, claims 49, 53, 54, 57, 59 shares the same problem as using the inhibitor of RANKL. Please clarify.
In addition, based on the results of clinical studies, applicant observed an association between fertility with a decreased level of OPG (section 0348-0349) and recited using antagonist or inhibitor of OPG. Thus the treatment of using OPG, i.e. increasing level of OPG, in claim 55 contradicts the effect. Please clarity.
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.
Claim 58 is rejected under 35 U.S.C. 101 the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) measuring natural molecules RANKL and OPG. Thus the law of nature refers to the (1) measuring natural molecules from a subject, i.e. RANKL and OPG in samples, and (2) correlating an increased or decrease levels of these two natural molecules for fertility status. Therefore, the natural relationship is the biomarker(s) correlating with a “condition” under judicial exception. (See Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012).
This judicial exception is not integrated into a practical application because no specific treatment is recited. It is noted the term “initiating treatment”, under broadest reasonable interpretation, can be construed as “resting” since MPEP 2106.04(d)(2) states “[e]xaminers should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.” (also see Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). Therefore no patentable weight is given on mere “treatment”.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all the sample obtaining, processing and measuring specific natural molecules are common, routine, and well-known in the field, such as ELISA and PCR (section 0158; Figures 5-6). These steps are recited at a high level of generality, and are necessary data gathering steps that feed into the determining step. One cannot do the determining step without getting the data. This weighs against it being significantly more.
Claim Rejections - 35 USC § 112
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, 41-57 and 59 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 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.
University of California v. Eli Lilly., 119 F.3d 1559, 43 USPQ2d 1398, the court held that a ‘representative number” of species is required possession of the genus - “structural features common to the members of the genus, which features constitute a substantial portion of the genus.” Enzo Biochem, Inc. V. Gen-Probe Inc, 1567, 43 USPQ2d at 1405, the court adopted the standard that “the written description requirement can be met by ‘show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “
The issue here is the term “antagonist or inhibitor of osteoprotegerin (OPG)”. The term “antagonist or inhibitor” is a genus. Unlike the agonists or stimulators of RANKL, which have many sufficient species, e.g. as recited in claims 44-45 (PTH, PTHRP, vitamin d, 250HD, 1.250H2D3, 24,250H2D3, Etalpha, IL-1, TNF, FSH, LH, a SIK inhibitor, YKL-05-099, IL-1,IL-6, IL-li, IL-17, TNF-a, vitamin D; also inhibitor such as AS2676293, ABD328, ABD345, SPD-304, and E09241 ), thus far applicant merely submits antibody or fragments thereof as the inhibitor (or antagonist)(see section 0224). Nevertheless, none of other molecules or compounds as antagonist or inhibitor of OPG have been disclosed in the specification. Therefore only ONE binding species (antibody) is not sufficient in justifying in possession of a whole genus “antagonist or inhibitor”.
The current application is free of prior art but subject to the above issues under 35 USC 101 and 112. The closest prior art is the applicant’s earlier application WO2016112916 where at page 8, line 14-19, applicant states:
PNG
media_image1.png
158
605
media_image1.png
Greyscale
This earlier application focused on male fertility, and applicant conducted different studies in verifying roles o RANKL and OPG played in male fertility (see examples). Applicant observed RANKL and OPG also expressed in ovary. Applicant then suggests “that modulation of the RANKL system also may be of importance for female reproductive function (emphasis added).
In view of the overall specification of this earlier application, particularly clinical studies on MALE alone from the examples, one ordinary skilled person would NOT immediately extrapolate these data to an anatomically, physiologically and pathologically distinct FEMALE, albeit the ovary also expressing RANKL and OPG. The statement above alone still needs actual experiment and/or clinical studies for corroboration.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGHWA J CHEU whose telephone number is (571)272-0814. The examiner can normally be reached 8 am to 8 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, Gregory Emch can be reached at 5712728149. 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.
CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678