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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/24/2026 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 1, 5, 9-14, 16-17, 19, 21-23, 27-28, 37, and 40 are pending (claim set as filed on 06/17/2026).
Priority
This application is a 371 of PCT/US2022/011109 filed on 01/04/2022, which has a provisional application no.: 63/134,062 filed on 01/05/2021.
Withdrawal of Rejections
The response and amendments filed on 06/17/2026 are acknowledged. Any previously applied minor objections and/or minor rejections, not explicitly restated herein for brevity, have
been withdrawn necessitated by Applicant’s formal corrections and/or amendments.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 essential claim rejections are detailed below in the Examiner’s response to arguments section.
Briefly, the previous anticipation rejections over the primary references of Broeckx and Cornish have been withdrawn necessitated by Applicant’s amendment to introduce the features of “at least 50 ng/mL of fibroblast growth factor 8” and “for at least 14 days”. Broeckx teaches FGF in a total concentration between 1 and 15 ng/mL and a duration of 3 days. However, note though that the Cornish reference is being reprised as secondary reference because it has applicable teachings to the concentration of FGF8.
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 §103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5, 9-14, 23, 27-28, 37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (WO 2020/206272 A2 – newly cited) in view of Cornish (US 2004/0266680 A1 – previously cited).
Lee’s general disclosure is directed to methods and compositions for producing populations of myogenic progenitor cells (see abstract & page 1, lines 13-24). Lee is further directed to methods for preventing or treating muscle diseases or disorders in a subject in need thereof (see page 31, lines 7-13).
Regarding an in vitro culture, Lee teaches a method for producing a population of myogenic progenitor cells (MPCs), the method comprising: differentiating a plurality of pluripotent stem cells in a cell culture medium comprising GSK-3, Notch inhibitor, and a basic fibroblast growth factor (FGF2) and/or fibroblast growth factor 8 (FGF8) (see pages 2-3, lines 18-3, & page 19, lines 21-26, & page 23, lines 25-27).
Regarding the duration, Lee teaches that the cells are allowed to differentiate for a number of days where the additional differentiation may last at least 14 days (see page 23, lines 9-13). Lee also teaches “a therapeutically effective amount of the composition (e.g., a composition comprising an MPC population) in humans can be administered. In one embodiment, the composition (e.g., a composition comprising an MPC population) is administered thrice daily, twice daily, once daily, fourteen days on (four times daily, thrice daily or twice daily, or once daily)” (see page 42, lines 17-28).
However, Lee does not teach: a concentration of at least 50 ng/mL of FGF8.
Cornish discloses that fibroblast growth factors (FGF) specify the differentiation, patterning, and proliferation of a variety of tissues (see ¶ [0002]). Cornish teaches the growth rate of cells stimulated by FGF-8 in concentrations 0, 5, 25, and 100 ng/mL (see Figures 1-2).
Regarding contacting in vivo, Cornish teaches administering an effective amount of FGF-8, FGF-8 analog, or a FGF-8 agonist to the patient (see abstract & ¶ [0031]-[0032]).
Regarding claim 13, claim interpretation: a wherein or whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited (MPEP 2111.04(I)). If the prior art teaches the same physical steps and conditions as in the claims, then the results or intended outcome should be inherent. Nonetheless, note that Cornish discloses that fibroblast growth factors (FGF) promote the proliferation of a variety tissues (see ¶ [0002]).
Regarding claim 23 pertaining to the FGF8 source, Cornish teaches FGF-8b isoform displays the most potent mitogenic activity in vitro (see ¶ [0003]). Cornish teaches human, mouse, or rat FGF8 polypeptides (see ¶ [0008]-[0014]).
Regarding claim 28 pertaining to the mammalian subject, Cornish teaches the patient may be a human, a horse, a dog, or a cat (see ¶ [0006]).
Regarding claims 37 and 40 pertaining to the FGF8 polypeptide sequence, Cornish teaches that “FGF-8a” is an isolated polypeptide of 204 amino acids in length. It includes mouse FGF-8a, rat FGF-8, and human FGF-8a, the sequences of which are shown below. Mouse FGF-8a (SEQ ID NO: 1) (see ¶ [0008]-[0015]). Claim interpretation: SEQ ID NO: 1 of the prior art corresponds with SEQ ID NO: 2 of the instant application as shown in the alignment below:
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to look to teachings of prior arts for suitable concentrations of FGF8 that can be used in the disclosure of Lee. Arriving at the secondary reference, Cornish teaches titrating concentrations of FGF8 upwards of the claimed concentration of at least 50 ng/mL (see Cornish at Figures 1-2). Moreover, note that the MPEP 2144.05(II)(A) states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Accordingly, it would have been readily apparent and within the purview of the ordinary to seek appropriate FGF8 concentrations in the culture medium as Lee discloses “If placed in cell culture, most myoblasts will proliferate if enough fibroblast growth factor (FGF) or another growth factor is present in the medium surrounding the cells. When the growth factor runs out, the myoblasts cease division” (see Lee at page 18, lines 5-12).
Claims 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Cornish as applied to the claims above, and in further view of Peterson (US 2015/0231183 A1 – previously cited).
Lee’s disclosure is taught above as it pertains to methods and compositions for producing populations of myogenic progenitor cells and methods for preventing or treating muscle diseases or disorders in a subject in need thereof (see Lee at page 31, lines 7-13).
However, Lee-Cornish does not teach: wherein the mammalian subject has osteoarthritis (claims 16-17); or a rotator cuff injury (claim 19).
Peterson discloses compositions comprising multipotent cells and a method thereof for treating tissue injury and diseases such osteoarthritis (see ¶ [0003], [0021]). “Injuries to soft tissues, such as muscles, tendons, ligaments, and joint capsules, occur quite frequently … Even despite surgical repair, about 15% of Achilles tendon and 40% of two tendon rotator cuff repairs subsequently fail” (see ¶ [0005]). Peterson teaches “a variety of growth factors have been used to improve tissue growth and migration to the wound site, as well as to promote angiogenesis” (see ¶ [0007]-[0008]). Peterson teaches FGF-8, FGF-9, or FGF-18 have been shown to have chondrogenic effect in vivo (see page 25: Table 15).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Cornish as applied to the claims above, and in further view of Gronthos (US 2015/0072422 A1 – previously cited).
Lee’s disclosure is taught above as it pertains to methods and compositions for producing populations of myogenic progenitor cells and methods for preventing or treating muscle diseases or disorders in a subject in need thereof (see Lee at page 31, lines 7-13).
However, Lee-Cornish does not teach: wherein the mammalian subject has a paraspinal injury and administering FGF-8 to the spine or to fat pads of the spine (claims 21-22).
Gronthos’ general disclosure relates to methods of enhancing proliferation and/or survival of mesenchymal precursor cells (MPC) and/or progeny derived therefrom in vitro or in vivo (see abstract). Gronthos teaches the cellular compositions may be used to treat patients with a cartilage condition, for example, rheumatoid arthritis or osteoarthritis or a traumatic or surgical injury to cartilage and other examples of bone conditions include meniscal tears, spinal fusion, spinal disc removal, spinal reconstruction, bone fractures, bone/spinal deformation, osteosarcoma, myeloma, bone dysplasia, scoliosis, osteoporosis et. al. (see ¶ [0092], [0150]).
Gronthos teaches “Routes of administration of the cells of the invention or compositions or components (e.g., ECM, cell lysate, conditioned medium) thereof include intramuscular, ophthalmic, parenteral, intraarterial, subcutaneous, oral, and nasal administration. Particular routes of parenteral administration include, but are not limited to, intramuscular, subcutaneous, intraperitoneal, intracerebral, intraventricular, intracerebroventricular, intrathecal, intracisternal, intraspinal and/or peri-spinal routes of administration” (see ¶ [0154]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to envisage the treatment of a paraspinal injury following the guidance of the cited references. The primary reference of Lee discloses methods for prevention and treatment of a variety of musculosketal disorders and Gronthos discloses conditions involving the spinal column (see Gronthos at ¶ [0092], [0150]). It would have been further obvious to administer FGF-8 to the spine or to fat pads of the spine as Gronthos discloses the routes of administration may include subcutaneous, intrathecal, intracisternal, intraspinal and/or peri-spinal routes of administration (see Gronthos at ¶ [0154]). The ordinary artisan would have had a reasonable expectation of success is because Cornish discloses that fibroblast growth factors (FGF) specify the differentiation, patterning, and proliferation of a variety of tissues (see ¶ [0002]). Thus, the administration of FGF-8 to the spine site of injury for repair would have been readily apparent to one of ordinary skill in the following the guidance of the cited references.
Conclusion
No claims were allowed.
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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