DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 03/09/2026 has been entered.
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 .
Status of the Claims
Claims 2, 6-9, 11-12, 16-17, 19-22, 24, 26, 28-30, and 41-42 are pending (claim set as filed on 03/09/2026).
Applicant’s election without traverse in the reply filed on 05/01/2025 of Group I directed to the method is again acknowledged. Claims 26 and 28-30 stand withdrawn as being directed to the non-elected invention.
Therefore, claims 2, 6-9, 11-12, 16-17, 19, 20-22 (rejoined), 24 (rejoined), and 41-42 (newly added) are under examination.
Priority
This application is a 371 of PCT/US2020/055921 filed on 10/16/2020, which has a provisional application no. 62/915,843 filed on 10/16/2019.
Withdrawal of Rejections
The response and amendments filed on 03/09/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
Briefly, the previously cited obviousness rejection from the prior office action has been withdrawn necessitated by Applicant’s amendments.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC §112, Enablement
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.
Claims 2, 6-9, 11-12, 16-17, 19, 20-22, 24, and 41-42 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated that: the test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands factors:
1) the nature of the invention,
2) the breadth of the claims,
3) the state of the prior art,
4) the predictability or unpredictability of the art,
5) the relative skill of those in the art,
6) the amount of direction or guidance provided,
7) the presence or absence of working examples,
8) the quantity of experimentation necessary
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands’ factors are relevant to the instant fact situation for the following reasons:
1) The nature of the invention and 2) the breadth of the claims
The claims are drawn to a method of making hydroxyapatite (HAP) by contacting non-osteoblast cells (that do not express alkaline phosphatase) with calcium, a phosphate salt, and 0.05-0.5 U/ml of an alkaline phosphatase to produce HAP within a week.
The breadth of independent/base claim 2 is broad with respect to unrecited concentrations of the essential ingredients/elements.
3) the state of the art, 4) unpredictability of the art and 5) the relative skill of those in the art
The relative skill of those in the art is high, generally that of a biochemist.
As indicated in the instant specification, in traditional protocols, “As is detailed in the Introduction, chemically synthesized HAP comes with several drawbacks including reduced bioactivity, and current methods for preparing HAP from natural sources are laborious and time
consuming, requiring incubation times of several months” (see pre-grant specification at ¶ [0004]-[0011], [0038] which describes the unpredictability in the art). Moreover, as further discussed by the specification, “As used herein, a ‘non-osteoblast cell’ refers to cells that are
not derived from an osteoprogenitor cell. These cells do not spontaneously produce HAP under normal physiological conditions, and must be provided with sufficient levels of calcium and a phosphate source to do so” (see ¶ [0039]).
There is no way for one skill in the art to know, a priori, how to make HAP at any concentration with a reasonable expectation of results. Thus, the state of the prior art does not support the broad scope of the above claims.
6) the amount of direction and guidance provided and 7) the presence and absence of working examples
The instant specification at ¶ [0100] discloses, reproduced herein for clarity:
PNG
media_image1.png
800
672
media_image1.png
Greyscale
PNG
media_image2.png
312
670
media_image2.png
Greyscale
Therefore, it appears that the instant specification is suggesting that the dose-dependent concentration of the ingredients is essential for biomineralization. However, the base claim does not recite all the necessary concentrations needed.
8) The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed above) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept the assertion that any concentration of the claimed ingredients could be predictably produce HAP within a week as inferred in the claims and contemplated by the specification.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent protection' is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (42 USPQ 2d 1001, Fed. Circuit 1997). To practice the invention of the instant claims requires undue experimentation due to unpredictability of HAP biomineralization by non-osteoblast cells and the lack of direction from Applicants regarding any concentrations, and would therefore require undue experimentation. The amount of experimentation required in order to produce HAP would require inventive effort and extensive experimental burden.
In light of the above discussion, the instant claims do not comply with the enablement requirement of 35 U.S.C. §112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Conclusion
No claims were allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 7-3 pm (EST).
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, Sharmila Landau can be reached on (571) 272-0614. 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.
/NGHI V NGUYEN/Primary Examiner, Art Unit 1653