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 status
Claims filed 6/11/2025 are entered. Claims 1-17 are pending and under examination.
Priority
This application is a Continuation application, filed 06/11/2025, of
US Patent Application 18221644, filed 07/13/2023, which is a Continuation application of
US Patent Application 16270211, filed 02/07/2019, which claims priority benefit of
Provisional Application 62627279, filed 02/07/2018.
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.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The analysis is below.
Step 1: Is the claim directed to a process, machine, manufacture, or composition of matter?
The claims are directed to a process.
Step 2A Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1 and dependent claims 2-17 are directed to an abstract idea and natural phenomenon.
Claim 1 is directed to measuring the contractility of contracted muscle before and after application of topical treatment material and comparing the measurements to determine if contraction was reduced or not. The recitation of the wherein clause, which is directed to the contractility of the muscle before and after treatment, is a natural phenomenon, as it is correlation that is a consequence of how the treatment affects the body. The dependent claims include this natural phenomenon.
Claim 11 is further directed to an abstract idea. The recitation that the images are “used to determine the effectiveness of treatment material to reduce the appearance of rhytides” is a mental process that encompasses the method done by the human mind.
Step 2A Prong 2: If so, does the claim recite additional elements that integrate the judicial exception into a practical application? If the additional elements provide integration into a practical application, then the claim is eligible.
The claims do not integrate the contractile activity differences before and after treatment into a practical application. The natural phenomenon is not specifically claimed to be used to direct a decision or treatment. The preamble recites an intended use of recited steps to determine the ability of a treatment material to reduce contraction of the facial muscle, but that is, itself the natural phenomenon. The dependent claims only generally limit the treatment material and its formulation, and the measurement of the contractile activity but these do not change depending on the results of the natural phenomenon. Dependent claims also include determining the effectiveness of the treatment material by comparing images of faces before and after treatment; however, this method is also well-known and routine in the art, as taught by Hanin (Abstract, and p. 18, section: Example 1). Therefore, none of the dependent claims integrate the natural phenomenon into a practical application.
Regarding claim 11, there are no additional elements in the claim beside the mental process of determining the effectiveness of the treatment.
Step 2B: If the claim is “directed to” a judicial exception, determine whether any additional element, or combination of additional elements, in the claim is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception.
The additional elements are insufficient to ensure the claims as a whole amount to significantly more than the judicial exception. In the context of quantitatively assessing muscle contraction to determine the ability of a treatment material (e.g. Clostridium neurotoxin) to reduce contraction in muscles, the steps of applying an external stimuli and measuring the contractile activity by measuring the CMAP is routine and well-known in the art to measure the quantitatively measure contractility, as seen by Harakawa (US 8,949,033 B2; Abstract). The step of administering the treatment material is necessary to determine the treatment’s effect and compare it with no treatment, and the determination that the treatment reduced muscle contraction when observing a reduction in muscle contraction after treatment amounts to no more than insignificant extra-solution activity as these are mere data gathering and observation of a natural result. The use of the method in facial muscle is a conventional because the administration of Clostridium neurotoxin, often formulated as BOTOX, is common in the face. The further limitations in the dependent claims are not a result or use of the natural phenomenon. In other words, the formulation and method of providing the electrical stimuli is independent of the reduction in contractility, so the natural phenomenon is not used to impact a decision.
Regarding claim 11, there are no additional elements in the claim beside the mental process of determining the effectiveness of the treatment.
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.
Claim 2 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.
Claim 2 recites “plant part” but it is unclear what is considered a plant part. Does it include only the plant structure or does it include all the extracts from a plant, such as water and compounds extractable from plants?
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 10-13, 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harakawa (Harakawa et al, US 8,949,033 B2, published 02/03/2015) in view of Hanin (Hanin et al, US 7,140,371 B2, published 11/28/2006) and Santus (Santus et al, Effect of short-term electrical stimulation before and after botulinum toxin injection, published 2011).
Regarding claim 1, Harakawa teaches a method for quantitatively assessing muscle contraction of a muscle in a person and determining the ability of a treatment material to reduce contraction of the facial muscle (Abstract). Harakawa teaches applying treatment to the left hind leg, which acts as the treatment group, but not the right hind leg, which acts as the untreated group. The method further comprises:
applying an external electrical stimulus to skin sufficient to contract the underlying muscle; and
measuring the contractile activity of the contracted muscle by measuring the compound motor action potential (CMAP) of the contracted facial muscle (col. 12, Example 1, lines 40-60),
which provides two CMAP measurements, one each for treated (left hind leg) and untreated (right hind leg) muscle.
The prior art differs from the claimed invention because the prior art takes parallel measurements of treated and untreated muscle from left and right analogous muscles in one subject, which encompasses the administration of the treatment material and repeating the steps of measuring the contractile activity (Abstract), while the claimed invention takes sequential measurements of treated and untreated muscles before and after treatment. Harakawa further teaches that the extent of a decrease in the CMAP amplitude quantifies the efficiency of the neurotoxin applied, i.e. treatment material (Abstract).
Harakawa does not explicitly teach repeating the steps of applying the external electrical stimulus and measuring CMAP of the contracted muscle to get a second measurement from the same muscle. Harakawa does not explicitly teach wherein a decrease in contractile activity based on the second average measurement as compared to the first average measurement indicates the treatment reduces contraction of the facial muscle when administered to the facial skin. However, the analogous results of getting and comparing a treated and untreated muscle reading from a parallelized method to determine reduction in contraction is taught by Harakawa, as discussed above.
Harakawa does not explicitly teach this method regarding the facial skin and facial muscle.
Harakawa does not explicitly teach administering the treatment material topically.
However, Hanin teaches quantifying the effects of the Clostridial toxin, such as botulinum toxin, upon a muscle, such as a frontalis muscle (Abstract). Hanin also teaches that topical application of botulinum toxin has been disclosed (col. 4, lines 50-53). Hanin also teaches that although skin topography can be used to assess an effect of topically applied botulinum toxin on muscle (col. 11, lines 25-31), electrophysiological measurements, such as surface electromyography (sEMG) can be used to more directly assess muscle activity and the pharmacodynamics of the botulinum toxin (col. 12, lines 27-33).
Harakawa and Hanin does not teach the sequential application of the external electrical stimulus, measuring the CMAP, administering treatment, and repeating the electrical stimuli and CMAP measurement to the same contracted muscle.
However, Santus teaches that electrical stimuli can be safely administered sequentially, before and after botulinum toxin injection with measurable CMAP, even for twenty-minute sessions (Abstract). Santus teaches that electromyography by CMAP amplitude measurement before and after botulinum toxin treatment is an objective and reproducible method to measure the effects of botulinum toxin on the muscle (p. 421, section: Discussion, para. 2 and 4).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that the contractility of untreated and treated muscle could be measured in sequence from the same muscle before and after treatment, instead of in parallel on different muscles, especially for muscles that may not have left and right analogues far enough from each other so that the effects of treatment are distanced from the untreated muscle. In summary, Harakawa provides one method to achieve the measurements in muscles that have separate left and right analogues. Hanin provides the use of botulinum toxin in facial muscles, such as muscles of the forehead where rhytides are prevalent and visible, which poses the new obstacle of separating the effects of treatment since the left and right side of the forehead are one muscle, unlike the separate hindlegs in Harakawa. Although, Santus teaches the sequential electrical stimulation and measurement of botulinum effects on the contractility of muscles also on different legs, this sequential method is applicable and compatible with facial muscles, and one skilled in the art would realize that both sequential and parallel methods can arrive at the same measurements.
One skilled in the art, before the effective filing date of the instant application, would be motivated to (a) study the effects of topical treatments, especially on facial muscles, since topical botulinum applications would be advantageous over injections to the face, and therefore, (b) choose a sequential contractility assessment method compatible with facial muscles.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that the sequential measurements of treated and untreated muscles would yield a similarly informative comparison as parallel measurements, and any effects from multiple stimulation is known and can be accounted for, as taught by Santus, and that this method is particularly suitable for facial muscles.
Claims 2-4, 10-13, 15-17 depend on claim 1. The teachings of the references regarding claim 1 are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding claims 2, 3, and 4, Harakawa further teaches the treatment material is a neurotoxin, specifically a botulinum toxin (Abstract), which is produced by the bacteria Clostridium botulinum (col. 1, lines 28-29), wherein the active center protein is called NTX (col. 1, lines 38-39), which is used in the method of Example 1 (col. 12, line 40).
Regarding claims 12 and 13, Harakawa further teaches that the CMAP is measured by an electromyograph from clip electrodes on the surface of the subject according to Figure 1 (col. 12, lines 50-56), which is known as a surface electromyography (col. 3, lines 8-10), and measures the compound muscle action potential, which is the electrical activity measured from the muscle between the surface electrodes.
Regarding claim 15, since Harakawa teaches the external electrical stimuli is used to contract the muscle (col. 4, lines 25-32), the method does not rely on the use of voluntary contractions by the subject.
Regarding claim 16, Harakawa does not explicitly teach the method for facial muscle. However, Hanin teaches a method of surface electromyographical (sEMG) quantification of the facial frontalis muscle activation, which is the muscle treated by the botulinum toxin and which the contractile activity measurement, CMAP, is taken from (col. 20, Example 2, e.g. lines 40-51, and lines 63-65). Regarding claim 17, the Specification defines rhytides to be types of wrinkles that show up on facial skin due to muscle contraction, and include frown or glabellar lines, forehead lines, crow’s feet, and more (instant Specification, p. 2, para. 0003). Hanin teaches the method is for comparing the effects of botulinum neurotoxin on skin wrinkle reduction in the frontalis muscle (Abstract), and teaches that subjects were selected to have “moderate” wrinkle severity on maximum voluntary contraction of the frontalis muscle and where brow furrow was due to muscle contraction.
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to choose a facial muscle where rhytides are prevalent, such as the frontalis muscle, to assess treatments that can reduce rhytides, and further to choose subjects with rhytides to test these treatments on.
One skilled in the art, before the effective filing date of the instant application, would be motivated to choose a facial muscle susceptible to rhytides from muscle contraction for the advantage of being able to test treatments that help reduce muscle contraction.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that the method used to test muscle contractions in other muscles of the body can be used and modified for facial muscle.
Regarding claims 10 and 11, Harakawa does not explicitly teach obtaining images of the facial skin before and after treatment to determine treatment effectiveness.
However, Hanin teaches a photographic method for determining effect of a botulinum toxin upon frontalis muscle wherein photographs of the face are taken following the sEMG procedures (col. 21, Example 3, lines 55-60), wherein response to treatment is determined by comparing the baseline image from untreated face to the images following treatment to the frontalis muscle (col. 22, lines 36-39).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that the additional photographic analysis method after a surface electromyography taught by Hanin could provide a visual supplement to the quantitative method of claim 1.
One skilled in the art, before the effective filing date of the instant application, would be motivated to add this visual representation of the contractility measurements for the advantage of showcasing the actual desired effects for patients – the visual reduction of wrinkles caused by contractions. Although a researcher may want a quantitative value to compare treatments objectively, a subject may not fully appreciate the quantitative contractility measurements without the visual manifestations of these quantifications.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that this photographic method can be added to the electromyography because it is independent of the electromyography, so would not interfere with it; and it is itself simple and noninvasive enough that it can be added with reasonably likelihood of success.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harakawa (Harakawa et al, US 8,949,033 B2, published 02/03/2015) in view of Hanin (Hanin et al, US 7,140,371 B2, published 11/28/2006) and Santus (Santus et al, Effect of short-term electrical stimulation before and after botulinum toxin injection, published 2011), as applied to claim 1 above, and further in view of Boggs II (Boggs, II et al, US9895530B2, published 2018).
Claim 14 depends on claim 1. The teachings of the references regarding claim 1 are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding claim 14, Harakawa teaches the external electrical stimulus but does not explicitly teach the shape of the conductive material generating the external electrical stimulus.
However, Boggs II teaches a method for providing electrical stimulation to a body by an electrode (Abstract) and teaches how the placement of the electrode determines the minimum intensity required to elicit muscle contraction (e.g. col. 16, lines 18-18). Boggs II further teaches nonlimiting examples of the electrode contact shapes, such as triangular and circular, and other shapes (col. 28, line 34), and teaches that changes in electrode shape, geometry, or surface area affects stimulus intensity in a calculable way, so the input energy would need to be modulated accordingly to get the desired output current density needed for muscle contraction (col. 28, lines 9-29).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that electrodes come in various shapes, one of which is circular, and that choosing any one of these shapes is compatible with the delivery of external electrical stimuli as long as the geometry and surface area is considered in calculating the required intensity.
One skilled in the art, before the effective filing date of the instant application, would be motivated to use electrode shapes that are common, such as circular, to help with reproducibility and accessibility of their methods.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success because the desired current density and action potential of the stimuli can be achieved by any electrode shape if its geometry is properly compensated for in the stimulus intensity.
Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harakawa (Harakawa et al, US 8,949,033 B2, published 02/03/2015) in view of Hanin (Hanin et al, US 7,140,371 B2, published 11/28/2006) and Santus (Santus et al, Effect of short-term electrical stimulation before and after botulinum toxin injection, published 2011), as applied to claim 1 above, and further in view of Dake (Dake et al, US 20050196414 A1, published 2005).
Claim 5-9 depend on claim 1. The teachings of the references regarding claim 1 are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding claim 5, Hanin teaches that targeted botulinum toxin has been used to treat various conditions, and topical application of a botulinum toxin has been disclosed (col. 4, lines 40-43 and 52-53). Dake specifically teaches topical application of botulinum toxin, particularly for treating facial muscles (Abstract), showing that topical skin treatments can affect underlying muscles. Dake teaches that topical application of botulinum toxin would provide for a safer and more desirable treatment alternative to injections due to its painless nature (p. 2, para. 0013). Regarding claims 6-9, Dake teaches the topical botulinum toxin treatment can be in the form of emulsions, gels, or solutions, or other forms, (p. 6, para. 0048), or ointments (p. 15, col. 1).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to assess the efficacy of topical treatments, especially for the face, as alternatives to more invasive an/or painful administration. It would be further obvious to formulate these topical treatments in the common forms taught by Dake, as they are applications that enable the stable delivery of the active compounds.
One skilled in the art, before the effective filing date of the instant application, would be motivated to formulate topical treatments for the advantages outlined by Dake, including less pain and safer and easier administration.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success that contractility of muscles can still be assessed from topical treatments, such as topical botulinum toxins, instead of injected treatments because Dake shows that topical treatments to the skin can affect the underlying muscles.
Double Patenting
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Patent No.: US 11,752,335 Bl
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. US 11,752,335 Bl (hereafter referred to as Patent ‘335). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, Patent ‘335 claim 1 recites all the claimed limitations and further provides a specific voltage for the electrical stimulus.
Claim 2-17 depend on claim 1. The teachings of the reference patent regarding claim 1 are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding the dependent claims, Patent ‘335 claims teach all the limitations according to the claim mapping below:
Instant claims
Patent ‘335 claims
2
2
3
3
4
4
5-9
5, 6
10
7
11
8
12
9
13
10
14
11
15
1
16
12
17
13
Patent No.: US 12,350,491 B2
Claims 1-17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. US 12,350,491 B2 (hereafter referred to as Patent ‘491). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, Patent ‘491 claim 1 recites all the claimed limitations and further provides a specific voltage for the electrical stimulus.
Claim 2-17 depend on claim 1. The teachings of the reference patent regarding claim 1 are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding the dependent claims, Patent ‘491 claims teach all the limitations according to the claim mapping below:
Instant claims
Patent ‘335 claims
2
2
3
3
4
4
5
5
6
6
7
7
8
8
9
9
10
10
11
11
12
12
13
13
14
14
15
15
16
16
17
17
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIRATH CHHAY whose telephone number is (571)272-0682. The examiner can normally be reached Mon-Thu 8AM-5PM EST.
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/BONIRATH CHHAY/ Examiner
Art Unit 1645
Wednesday, August 19, 2026
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 20, 2026
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