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 .
Election/Restrictions
Applicant elected the species ‘population of cells ‘ in claim 3 without traverse and respectively the relevant claims 1-3, and 8-11, in the reply filed on 03/13/2026 is acknowledged and no new claims were added.
Claims 4-7 were withdrawn from further consideration in pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/13/2026.
Claims 12-16 were previously cancelled.
Claim status
Claims 1-11 are pending.
Claims 4-7 are withdrawn.
Claims 12-16 are cancelled.
Claims 1-3, and 8-11 are under examination.
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 1-3 and 8-11 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 delivery of cells to the cochlea through round window of the inner ear, does not reasonably provide enablement for treatment of an auditory disease or condition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make use the invention to, treat any auditory disease or condition commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, the enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (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 presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
The nature of the invention:
The claims are drawn to a method of treatment of an auditory disease or condition in a human subject, by administering a therapeutic agent into a cochlea of the subject via the round window membrane.
Breath of the claims:
The independent claim (claim 1) taken together with the specification reads on a method of treating any auditory disease or condition in humans with administration of any therapeutic agent into the cochlea of the ear. Also claim 3 recites, the therapeutic agent comprising a population of cells which reads on any cell type, which can be either fully or partly differentiated (as recited in claim 8) or comprised of stem or progenitor cells (as recited in claim 10). However, the claims as written do not read on any therapeutic outcome.
The state of the prior art:
The most prevalent cause of acquired haring loss is degeneration of cochlear hair cells, cell-based therapies based on stem and pluripotent cells have demonstrated potential for generating differentiated cells to replace lost or damaged hair cells (Takeda et al., abstract, page 823, and cell transplantation-based strategies for regeneration, page 829). It appears that the most common way to transplant cells into the inner ear to treat auditory diseases is through accessing the bony cavity of cochlea through the round window. Takeda et al. suggest that the most direct way of transplanting cells to organ of corti (located in the bony cavity of cochlea and contain hair cells) is through fenestration of the round window membrane. Timing of the transplantation including, the developmental stage of the recipient, interval between the injury and the transplantation and the stage of differentiation of the grafted cells can affect the transplantation success (Takeda et al., fig.4, page 834). Coleman et al., 2005 teaches microinjection of partially differentiated mouse embryonic stem cells into guineapig cochlea of deafened guinea pigs (abstract, page 369). Lang et al., 2008 teaches injection of mouse embryonic stem cells in to Rosenthal canal of cochlea through the round window of inner ear into an auditory neuropathy animal model (title, abstract, page 224, fig.1, page 227).
The predictability or unpredictability of the art:
The state of the art of cell-based therapies for auditory disease/conditions is unpredictable and significant challenges remain in the field. The ideal parameters for variables such as timing after injury and the stage of differentiation of transplant cells are not yet well understood. Continued research in this area is needed to overcome the challenges in cell-based regenerative therapies for hearing loss (Takeda et al., pages 835-836). Takeda also teaches that many groups have evaluated the feasibility of stem cell transplantation into inner ear as a treatment for hearing loss, over the past two decades. Survivability of transplanted stem cell derived progenitors in the inner ear appears to be short. Takeda summarizes various studies that evaluated inner ear stem-cell transplantation (table 2, page 831), and the stem cell survivability including the stem-cell derived neural progenitors ranged from 11 days to 10 weeks maximum. Takeda also teaches that while the previous findings offer encouragement, stem cell transplantation into cochlea rather than the auditory nerve has been mixed (cochlear transplant, page 831).
The relative skill of those in the art:
The relative skill of those in the art is high, requiring a graduate degree.
The amount of guidance presented:
The claims are drawn to a method for the treatment of an auditory disease or condition. The claims and specification taken together do not provide guidance on the outcome of the therapeutic agent administered into the cochlea of the subject.
The presence of working examples:
Specification provides guidance to identify the Rosenthal’s canal as a possible route of administration of cells into human cochlea, via synchrotron radiation phase -contrast imaging (example 1 of the instant application, page 13), and teaches a route to access the canalis cochlearis by exposing the round window membrane surgically (example 2 of instant application, page 17) and injection of otic progenitor cells into the canalis cochlearis or the Rosenthal’s canal. Otic progenitor cells mixed with a contrast media were injected into the Rosenthal’s canal and the contrast media was traced to analyze the distribution of the injected cells (example 3 of instant application, page 19). A pilot study for administration of cell-based treatment to human patients is proposed with more in-depth assessment of cell survivability , auditory nerve function, and hearing and speech perception testing (instant application, page 22).
The duration of the tracing experiment after injection of the cells is not disclosed and the specification fails to clarify the survivability and functionality of the transplanted cells in the inner ear.
The specification also fails to provide any working examples of therapeutic outcomes of the treatment.
The quantity of experimentation necessary:
The claims and specification when taken together recite a route of administration of otic cells in to the cochlea of a subject, but fails to validate the claimed method as a treatment for any auditory disease. Therefore, would cause any person of ordinary skill in the art to perform an undue amount of experimentation to utilize the claimed invention to treat an auditory disease or condition.
Also, a person of ordinary skill in the art would be burdened with an undue amount of experimentation to determine what population of cells to use as the therapeutic agent as recited in claim 3. Also, what population of fully or partially differentiated cells to use as the therapeutic agent as recited in claim 8.
Therefore, claims 1-3 and 8-11 are rejected under 35 U.S.C. 112, first paragraph, for scope of enablement.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-3 and 8-11 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Coleman, B., et al., Cell transplantation 15.5 (2006): 369-380 as evidenced by Haberberger, et al., Frontiers in cellular neuroscience 13 (2019): 271.
Regarding claim 1 and 10, Coleman teaches administration of mouse embryonic stem cells treatment for deafened guinea pig cochlea through the round window (abstract, page 369, fig.1, page 370).
Regarding claim 2, Coleman teaches mouse embryonic stem cells administration into deafened guinea pigs (abstract, page 369), and also teaches that effective treatment for hearing loss is replacement of degenerated spiral ganglion neurons which can be achieved with cell based therapy (introduction, paragraph 2, page 369)
Regarding claim 3 and 8 , Coleman teaches partially differentiated, mouse embryonic stem cells treatment for deafness in guinea pigs (abstract, page 369).
Regarding claim 9, Coleman teaches variety of methods used in other studies to deliver cells to the cochlea (table 1, page 371), one such method is to replaced spiral ganglion neurons using dorsal root ganglion explant in guinea pig and rat models (table 1, page, 371). The dorsal root ganglion is known to contain sensory neurons as evidenced by Haberberger, et al., (abstract, page 1).
Regarding claim 11, Coleman teaches the delivery of replacement cells to the target site, Rosenthal’s canal of the cochlea (introduction, paragraph 2, page 369, fig. 1, page 370).
Therefore the claimed invention is anticipated by the reference.
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HASHANTHI ABEYRATNE-PERERA whose telephone number is (571)272-6562. The examiner can normally be reached Monday-Friday 7:30 am- 5:00pm.
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, Peter Paras can be reached at 571-272-4517. 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.
/HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632
/PETER PARAS JR/ Supervisory Patent Examiner, Art Unit 1632
Prosecution Insights