DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 16 January 2026 in which claims 2, 6 and 10-20 were canceled, claims 1, 3, 4, 5, 7, 8 and 9 were amended to change the scope and breadth of the claims, and claims 21-39 were newly added.
Claims 1, 3, 4, 5, 7-9 and 21-39 are pending in the current application and are examined on the merits herein.
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 .
New & Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 16 January 2026, where the limitations in pending claims 1, 3, 4, 5, 7, 8 and 9 as amended now have been changed and claims 21-39 have been newly added. Therefore, rejections from the previous Office Action, dated 21 October 2025, have been modified and are listed below.
Claim Rejections - 35 USC § 112(a)
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, 3-5, 7-9 and 21-39 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. This is a NEW MATTER rejection.
The recitation “wherein the one or more injections are made into the soft tissue tissue immediately adjacent to the cranial insertions of one or more cervical-origin muscles that insert on the posterior skull” in claims 1, new claim 28 and new claim 39 appears to be new matter.
The specification provides support for making injections into, or immediately adjacent to the soft tissue attachments to the subject’s posterior skull.
At para [0024] of the published application, The specification states “As used herein, “soft tissues” refer to supportive and/or connective body tissues, including, without limitation, muscles, tendons, ligaments, and aponeuroses. Soft tissue attachments to the posterior skull include, without limitation, the fibro-osseous attachment sites of the splenius capitis muscle, semispinalis capitis muscle, trapezius muscle, rectus capitis posterior major and minor muscles, and obliquus capitis superior muscle. As used herein, a “fibro-osseous attachment” or “fibro-osseous attachment site” refers to a point at which a tendon or ligament attaches to bone. In some embodiments, the injections are made into the medial (toward the midline of the body) and/or lateral (away from the midline of the body) aspects of the semispinalis capitis insertion and/or the medial and lateral aspects of the splenius capitis insertion (as determined by palpation). As used herein, “origin” or “tendinous origin” and “insertion” or “tendinous insertion” refer to the two anchoring points of a muscle (one at each end), with the tendon attached to a more fixed bone at the origin and to a more mobile bone at the insertion. The semispinalis capitis and splenius capitis are superficial to other muscles that attach to the posterior skull, and injection of the insertions of these deeper muscles to the posterior skull may occur when injecting the insertions of the semispinalis capitis or splenius capitis, and such injections are encompassed in this invention. Injections may likewise be made into or spread into the occipitalis muscle, which attaches along the superior margin of the superior nuchal line. In some embodiments, the injections are made directly into the tendinous insertions or fibro-osseous attachments of these muscles to the posterior skull. Injections may acceptably be made into soft tissue immediately adjacent to the bony attachments of tendon to the palpated locations, as long as the injected volume of hyaluronic acid is sufficient to spread to these attachments. Larger injection volumes and dosages may allow for injection at greater distances from these locations.”
It is not clear whether any of the aforementioned muscles are encompassed by “cervical-origin muscles”, let alone which one are included and/or excluded.
To overcome the rejection, Applicant could amend the claims to delete the newly added limitation for which there is not clear support, and replace it with any of the specific muscles/locations described in the Specification, e.g. the splenius capitis and semispinalis capitis).
The recitation “a ½” to 1” distance lateral or inferior to the posterior mastoid process” in present claims 3 and 29, does not appear to have support from the Specification”.
The recitation “wherein the two or more injections are spaced at horizontal interval of about ½” to about 1” in present claim 4, does not appear to have support from the Specification”. While the originally presented claims and Specification provide support for two or more injections spaced at an interval of about ½” to about 1”, there is no specific teaching that these two or more injections are spaced IV. The recitation “two or more treatment periods…once per week for 2 to 3 weeks” in newly added claim 9 does not have support from the Specification.
Newly added claims 24 and 36 directed to “treating a migraine headache pain located ipsilaterally to the splenius capitis muscle” does not appear to have support from the Specification.
Newly added claim 25 does not appear to have support from the Specification.
Newly added claim 26 does not appear to have support from the Specification.
The recitation “wherein the treatment periods are separated by 3 to 6 months” in newly added claim 33 does not appear to have support from the Specification. The Specification only provides support for treatment periods of about 6 months”.
The recitation “at least 5 mg/mL” in newly added claim 34, and the recitation “at least 10 mg/mL” in newly added claim 35, without the recitation of an upper range is not supported by the present Specification. The present Specification supports an upper limit of 25 mg/mL, whereas at least 5 mg/mL includes values above that, including 50 mg/mL, or 100 mg/mL, none of which are disclosed.
Newly added claim 37 does not have support from the Specification.
Newly added claim 38 does not have support from the Specification.
Claim Rejections - 35 USC § 112(b)
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.
Claim 26 is 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.
The recitation “wherein at least 60 mg of hyaluronic acid…” in claim 26 renders the claim herein indefinite. Claim 26 depends from claim 25, which depends from claim 21. None of these claims recite an amount or concentration of hyaluronic acid. Because the claim say “wherein”, it is not clear if this claim is further limiting. The claim could be amended to recite “further comprising administering…”. Note, however, the claim appears to also introduce new matter, as discussed above.
Response to Arguments
Applicant's arguments filed 16 have been fully considered but they are not persuasive.
Applicant contends Wu et al. is not enabling for any therapeutic benefit of hyaluronic acid in migraine. Applicant argues that since Wu et al. is not enabled, it cannot anticipate.
The above arguments have been carefully considered, but they are not found persuasive, because the present claims are not limited to only administering hyaluronic acid. Rather, claim 1 recites “comprising administering to the subject by one or more injections a composition comprising…”.
The recitation “comprising” is a transitional phrase, which means the claim does not exclude a step of administering a botulinum toxin, or administering a composition having both hyaluronic acid and botulinum toxin.
See MPEP 2111.03, which states “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.
The rejection could be overcome by excluding “botulinum toxin”.
The rejections are hereby maintained.
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.
Claim(s) 1, 7, 8, 28, 30, 31, and 39 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Wu et al. (US Patent Application Publication No. 2020/0108129, cited in previous Office Action) as evidenced by Physiopedia (https://www.physio-pedia.com/Trapezius, cited in PTO-892).
Wu et al. disclose a pharmaceutical composition comprising (i) a Clostridial toxin active ingredient; and (ii) a non-crosslinked hyaluronic acid (HA) or salt thereof, wherein the weight average molecular weight (Mw) of the non-crosslinked HA is from 250 kDa to 2400 kDa (claim 1). The Mw can also range from about 450 kDa to 2,000 kDa (claim 16). Exemplified HA have a MW of 401 kDa and 683 kDa (referred to as LMW and 700, respectively), (para [0205]). The pharmaceutical composition may further comprise a pharmaceutically acceptable carrier (para [0003], [0126]). The concentration of the HA ranges from 0.1 to 50 wt.% based on the total weight of the solid or liquid, including 0.2 to 10 wt.%, or from about 0.4 to 5 wt.% (para [0066]). The composition can be used to treat conditions that are of a neuromuscular nature, including headaches in adult patients with chronic migraines (para [0078]; [0230]). Additional disorders include tension headaches (para [0231]). Wu et al. expressly disclose treating a patient suffering from migraine headache pain, the method comprising administering between about 0.5 to 200 U per treatment of the pharmaceutical composition, wherein a treatment can comprise multiple treatments (para [0243]). For example, a patient can be treated with injections at 2-32+ sites, including 6 injections (5U each) at the trapezius muscles (para [0242]). Similar treatments can be applied to tension headache pain (para [0246]). Wu et al. disclose administering the composition to treat headache pain by administering the composition to an afflicted area of the patient (para [0248]). The repeat time can vary from about 1 week to about 50 weeks, however, a common range is about 4 to about 25 weeks, or even about 12 weeks to about 16 weeks (para [0259]).
The trapezius muscle corresponds to label 200 in figure 2 (see present claim 10).
As evidenced by Physiopedia, the trapezius muscle extends from the cervical to thoracic region on the posterior aspect of the neck and trunk. Thus, as evidenced by Physiopedia, Wu et al. disclose injecting into the soft tissue immediately adjacent to the cranial insertions of one or more cervical-origin muscles that insert on the posterior skull as recited in amended claim 1.
Wu et al. disclose a method of treating a migraine headache in a subject, comprising one or more injections of a pharmaceutical composition comprising HA, wherein the injections are made at the trapezius muscles, i.e. into the soft tissue immediately adjacent to the cranial insertions of one or more cervical-origin muscles that insert on the posterior skull as recited in amended claim 1.
The recitation “wherein the hyaluronic acid injections alone are sufficient to produce a therapeutic effect in treating migraine” in claim 28 is a latent property of the hyaluronic acid. However, it does not exclude administering additional unrecited agents. Similarly, the recitation “without requiring the presence of any other therapeutic agents” in newly added claim 28 does not exclude the presence of any other therapeutic agents.
The recitation “consisting essentially of” in newly added claim 39 is broadly and reasonably interpreted as comprising. In particular, the Examples in the Specification describe administering hyaluronic acid and botulinum toxin. This interpretation is in accordance with MPEP 2111.03, which states “For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising."
Wu et al. teach HA having a MW of 401 kDa, which is about 500 kDa. Wu et al. also teach using an HA having a MW of 683 kDa, which lies within the range of present claims 7 and 8.
Thus, the disclosure of Wu et al. anticipates claims 1, 7, 8, 28, 30, 31, and 39 of the present application.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 4, 7-9, 22-23, 26, 28-31, 33-35 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (US Patent Application Publication No. 2020/0108129, cited above) in view of Brooks et al. (US Patent Application Publication No. 11,826,405, cited in previous Office Action).
Wu et al. teach as discussed above.
Wu et al. do not expressly disclose injecting into soft tissue attachments within about ½” to about 1” from the superior nuchal line or inferior nuchal line of the subject’s skull (present claims 3, 29). Wu et al. do not expressly disclose administering two or more injections along the subject’s superior nuchal line and/or inferior nuchal line, and wherein the two or more injections are spaced at an interval of about ½” to about 1” (present claim 4).
Brooks et al. teach the number of injections to the occipitalis per side (reference numerals 10, 11 and 12 in fig. 4; mid-point of nuchal ridge (nuchal line) for the first injection, which is done above the ridge), (table 1). The second and third injections form an inverted triangle with the first, and there is about 2-3 cm (0.79-1.18 inches) between each injection point. The headache treatment can be repeated after 4-24 weeks (col. 35:35-47). The occipital region attaches along the superior margin of the superior nuchal line (see p.8 of the present Spec). Thus, an injection above the ridge is above the superior nuchal line.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to inject (two or more times) the composition of Wu et al. within 0.79-1.18 inches from the superior nuchal line; and the two or more injections are spaced at intervals of about 0.79-1.18 inches.
Starting from Wu et al., the ordinary artisan would have looked to the teachings of Brooks et al. because they are both concerned with the use of a neurotoxin for the treatment of headaches and migraines. The ordinary artisan would have been motivated to inject the toxin-HA containing composition of Wu et al. along the superior nuchal line, based on the guidance provided by Brooks et al. for treating headaches. Brooks et al. teach multiple injections should occur at intervals of 2-3 cm, equivalent to 0.79-1.18 inches. The teaching of 0.79-1.18 inch interval suggests injecting about 0.79-1.18 inches within the superior nuchal line. Thus, one having ordinary skill in the art would have been motivated to inject the toxin-HA containing composition of Wu et al. at intervals of about 0.79-1.18 inches around the superior nuchal line.
The concentration of 5 mg/mL to about 20 mg/mL in present claim 22 is equivalent to 5-20% w/v. As noted above, Wu et al. teach administering HA at concentrations ranging from 0.1 to 50 wt.% based on the total weight of the solid or liquid. This range taught by Wu et al. encompasses the claimed range. Wu et al. further teach a range of HA including 0.2 to 10 wt.%. This range overlaps with the claimed ranges. An amount of 60 mg is close in value to the amount recited in present claim 26.
The prior art teach treating a patient with at least 6 injections, at 2-32+ injection sites. Wu et al. teach HA having a MW of 401 kDa, which is about 500 kDa. Wu et al. also teach using an HA having a MW of 683 kDa, which lies within the range of present claims 7, 8, 30, and 31.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. and Brooks et al. as applied to claims 1, 3, 4, 7-9, 22-23, 26, 28-31, 33-35 and 39 above, and further in view of Robbins et al. (Headache, 2014, vol. 54, pp.1441-1459, cited in previous Office Action).
Wu et al. teach as discussed above.
Wu et al. do not expressly disclose identifying an injection site by palpating and selecting areas of pain or tenderness for injection (present claim 5).
Brooks et al. teach as discussed above.
Robbins et al. teach trigger point injections (TPIs) are a useful adjunctive treatment for the most common headache disorders (abstract). Trigger points (TPs) area identified by physically examining for signs of pain, which may be present in primary and secondary headache disorders (p.1442, first para). TPIs are frequently employed methods to treat headache disorders and alleviate head and neck pain (p.1442, third para). Robbins et al. teach the examiner can identify taut bands in muscles that reproduce pain by pressing symptomatic areas with enough pressure to blanche the fingernail or to elicit a report of discomfort. The examiner should press or squeeze the trapezius at the shoulder, the splenius capitis as well as the semispinalis capitis to try to reproduce all aspects of the patient’s headache pain (p.1446, Indications: Physical Exam, Posture). Robbins et al. teach “The areas that the patient reports as painful can be used as a marker for identifying muscles to be selected for TPI” (p.1446, penultimate para). Robbins et al. teach first palpating to identify the TP (p.1448). Robbins et al. teach TPs in the semispinalis capitis (fig.6) can refer pain to the head, neck, and shoulders, usually manifesting as suboccipital and upper back pain (p.1450, third para). The trapezius is one of the most common muscles selected for TPIs (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify one or more injection sites by palpating the attachment sites of semispinalis capitis, trapezius and/or splenius capitis, selecting areas of pain or tenderness on palpating for injection.
According to the teachings of Robbins et al., one of ordinary skill in the art would have known palpating for pain is the standard method for identifying trigger points in a subject suffering from headaches. Furthermore, the method of injecting a needle into trigger points (TPIs) is a commonly used method for alleviating headache pain and symptoms thereof. The ordinary artisan would have been motivated to palpate for pain, and then inject a needle having the composition of Wu et al. into the trigger points based on the guidance provided by Robbins et al. The ordinary artisan would have been motivated to inject into the semispinalis capitis because it is a known muscle that can refer pain to the head, neck, and shoulders, usually manifesting into suboccipital pain.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 5, 24 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., Brooks et al. and Robbins et al. as applied to claims 1, 3, 4, 5, 7-9, 22-23, 28-31, 33-35 and 39 above, and further in view of Kim et al. (Life, 2024, published December 2023, vol. 14, no. 57, 12 pages, cited in PTO-892).
Wu et al. teach as discussed above.
Wu et al. do not expressly disclose treating the splenius capitis insertion site (present claims 5, 24 and 36).
Brooks et al. teach as discussed above.
Robbins et al. teach as discussed above.
Kim et al. is concerned with the use of sympathetic nerve entrapment point saline (SNEP) injections to achieve long-term pain relief in patients with migraine. The injections were repeatedly administered to the splenius capitis (SC). The SC is a pericranial muscle and originates from the spinous process of the C7-T4 vertebrae (p.9, second para). The insertion points are directed upward and laterally, extending to the occipital bone immediately below the lateral one-third of the superior nuchal line, as well as the mastoid process of the temporal bone and underneath the sternocleidomastoid muscle. Kim et al. identified patients with active SC tender points during physical examination (p.2-3, bridging para).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to identify one or more injection sites by palpating the attachment sites of semispinalis capitis and/or splenius capitis, selecting areas of pain or tenderness on palpating for injection.
According to the teachings of Robbins et al., one of ordinary skill in the art would have known palpating for pain is the standard method for identifying trigger points in a subject suffering from headaches. Furthermore, the method of injecting a needle into trigger points (TPIs) is a commonly used method for alleviating headache pain and symptoms thereof. The ordinary artisan would have been motivated to palpate for pain, and then inject a needle having the composition of Wu et al. into the trigger points based on the guidance provided by Robbins et al. The ordinary artisan would have been motivated to inject into the semispinalis capitis because it is a known muscle that can refer pain to the head, neck, and shoulders, usually manifesting into suboccipital pain.
Furthermore, the ordinary artisan would have been motivated to inject near the SC as recited in present claims 24 and 36, because Kim et al. found SNEP injections around the SC achieved long-term pain relief in patients with migraine. The insertion points are directed upward and laterally, extending to the occipital bone immediately below the lateral one-third of the superior nuchal line, as well as the mastoid process of the temporal bone and underneath the sternocleidomastoid muscle.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699