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’s election without traverse of invention V in the reply filed on 3 August 2026 is acknowledged.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim – all claims starting with new claim 27 are improperly separated from the claims from which they depend. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n). Future amendments to the claims should follow the proper numbering format or may be found non-responsive.
Claim 23 is objected to because of the following informalities:
Claim 23 defines an assembly comprising a list of components, but lacks an “and” before the final listed components, only including one before a wherein clause further defining these components; it is unclear if an element has been omitted or if this is merely a formatting error.
Appropriate correction is required.
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 26, 28, 30, 32, 34, 36, 38, 40 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. Claims 26 and 28 define an assembly with one electrode configured to be positioned on an adductor pollicis muscle and another to be positioned on a dorsal interosseous muscle. The disclosure of the instant invention only describes assemblies that have electrodes positioned on only one of these two locations – paragraph [0077] as filed defines “The electrode 204 may be positioned at the adductor pollicis muscle or the first dorsal interossei muscle” and does not define any electrode being positioned at the other alternative, only further comprising an electrode on a finger, see paragraphs [0078]-[0079]. Paragraph [0083] defines a plurality of electrodes but only sets forth that they “can read activity of the adductor pollicis muscle, the dorsal interossei (e.g., the first dorsal interosseus), the orbicularis oris muscle, or the flexor hallucis longus muscle, etc.”, again with these locations only presented as alternative options not both being present in the same assembly. At no point is an assembly defined, described, or illustrated with electrodes configured to be positioned at both the adductor pollicis and the dorsal interosseous, such that the disclosure does not reasonably convey possession of such an assembly at the time the invention was filed.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 24-42 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). At least claims 24-28 positively recite the human body – “to position the plurality of sensing electrodes at anatomical positions on a hand”, “a thumb aperture to secure the base around a thumb”, etc. The invention should be defined in terms of what it is configured to do relative to the human body, not positively reciting the human body as part of the invention itself.
Claim Rejections - 35 USC § 102
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.
Claim(s) 23, 24, 41, 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner (US 2016/0313801).
Regarding claim 23, Wagner discloses a neuromuscular lead assembly, comprising:
a base (element 520);
a plurality of stimulation electrodes mechanically supported by the base and configured to be connected to a patient (elements 110, 527; paragraphs [0140]-[0142], [0205], [0208])
a plurality of sensing electrodes supported by the base and configured to be in electrical communication with the patient, the plurality of sensing electrodes also being configured to electrically communicate with a processor to detect muscle activity in response to a stimulation from at least one of the plurality of stimulation electrodes to the patient (elements 104, 106, 108, 532; paragraphs [0140]-[0142], [0205], [0208]); and
wherein a first sensing electrode, a second sensing electrode, and a third sensing electrode of the plurality of sensing electrodes are respectively configured as a positive electromyographic detection electrode, a driven electrode to suppress a common-mode noise signal, and a negative electromyographic detection electrode (paragraph [0141]).
Regarding claim 24, Wagner further discloses that the base is nonlinear and configured to position the plurality of sensing electrodes at anatomical positions on a hand of the patient and the plurality of stimulation electrodes at anatomical positions on a forearm of the patient (figure 21B).
Regarding claim 42, any object can be disposed of if so desired, such that Wagner’s neuromuscular lead assembly is inherently disposable.
Regarding claim 41, any object can be disposed of if so desired, such that Wagner’s neuromuscular lead assembly is inherently disposable.
Claim Rejections - 35 USC § 103
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) 25-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wagner in view of Linderman (US 2012/0172682).
Regarding claim 25, Wagner further discloses that the base includes a thumb aperture configured to secure the base around a thumb of the patient (figure 21B, a glove); Wagner does not further disclose that the first sensing electrode is positioned on one of a palm or a back of a hand of the patient, and the second sensing electrode is positioned on the other of the palm or the back of the hand. Linderman teaches a neuromuscular lead assembly glove comprising a plurality of electromyographic sensing electrodes configured to detect muscle activity in a patient (paragraph [0173]) in response to a stimulation (paragraph [0126]), where a first sensing electrode is configured to be positioned to be on one of a palm or a back of a hand of the patient and another sensing electrode is configured to be positioned on the other of the palm or the back of the hand of the patient (paragraph [0173]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the assembly of Wagner with one sensing electrode configured to be positioned on the palm and another configured to be positioned on the back of the hand, as taught by Linderman, in order to ensure sensing of movements in all directions.
Regarding claim 29, Wagner’s sensing electrodes are designed to be used anywhere on the body, including on a finger.
Regarding claim 33, Wagner further discloses that the third sensing electrode is the negative electromyographic detection electrode (paragraph [0141]).
Regarding claim 37, Wagner further discloses placing a sensing electrode on an index finger of the patient (figure 21B).
Regarding claim 26, Wagner further discloses that the base includes a thumb aperture configured to secure the base around a thumb of the patient (figure 21B, a glove); Wagner does not further disclose that the first sensing electrode is configured to be positioned on one of an adductor pollicis muscle or a first dorsal interosseous muscle of the patient, and the second sensing electrode is configured to be positioned on the other of the adductor pollicis muscle or the first dorsal interosseous muscle. Linderman teaches a neuromuscular lead assembly glove comprising a plurality of electromyographic sensing electrodes configured to detect muscle activity in a patient (paragraph [0173]) in response to a stimulation (paragraph [0126]), where a first sensing electrode is configured to be positioned on one of an adductor pollicis muscle or a first dorsal interosseous muscle of the patient and another sensing electrode is configured to be positioned on the other of the adductor pollicis muscle or the first dorsal interosseous muscle (paragraph [0173]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the assembly of Wagner with one sensing electrode configured to be positioned on the adductor pollicis and another configured to be positioned on the first dorsal interosseous, as taught by Linderman, in order to ensure sensing of movements in all directions.
Regarding claim 30, Wagner’s sensing electrodes are designed to be used anywhere on the body, including on a finger.
Regarding claim 34, Wagner further discloses that the third sensing electrode is the negative electromyographic detection electrode (paragraph [0141]).
Regarding claim 38, Wagner further discloses placing a sensing electrode on an index finger of the patient (figure 21B).
Regarding claim 27, Wagner further discloses that the base includes a thumb aperture configured to secure the base around a thumb of the patient (figure 21B, a glove); Wagner does not further disclose that the first sensing electrode is positioned on one of a palm or a back of a hand of the patient, and the second sensing electrode is positioned on the other of the palm or the back of the hand. Linderman teaches a neuromuscular lead assembly glove comprising a plurality of electromyographic sensing electrodes configured to detect muscle activity in a patient (paragraph [0173]) in response to a stimulation (paragraph [0126]), where a first sensing electrode is configured to be positioned to be on one of a palm or a back of a hand of the patient and another sensing electrode is configured to be positioned on the other of the palm or the back of the hand of the patient (paragraph [0173]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the assembly of Wagner with one sensing electrode configured to be positioned on the palm and another configured to be positioned on the back of the hand, as taught by Linderman, in order to ensure sensing of movements in all directions.
Regarding claim 31, Wagner’s sensing electrodes are designed to be used anywhere on the body, including on a finger.
Regarding claim 35, Wagner further discloses that the third sensing electrode is the negative electromyographic detection electrode (paragraph [0141]).
Regarding claim 39, Wagner further discloses placing a sensing electrode on an index finger of the patient (figure 21B).
Regarding claim 28, Wagner further discloses that the base includes a thumb aperture configured to secure the base around a thumb of the patient (figure 21B, a glove); Wagner does not further disclose that the first sensing electrode is configured to be positioned on one of an adductor pollicis muscle or a first dorsal interosseous muscle of the patient, and the second sensing electrode is configured to be positioned on the other of the adductor pollicis muscle or the first dorsal interosseous muscle. Linderman teaches a neuromuscular lead assembly glove comprising a plurality of electromyographic sensing electrodes configured to detect muscle activity in a patient (paragraph [0173]) in response to a stimulation (paragraph [0126]), where a first sensing electrode is configured to be positioned on one of an adductor pollicis muscle or a first dorsal interosseous muscle of the patient and another sensing electrode is configured to be positioned on the other of the adductor pollicis muscle or the first dorsal interosseous muscle (paragraph [0173]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the assembly of Wagner with one sensing electrode configured to be positioned on the adductor pollicis and another configured to be positioned on the first dorsal interosseous, as taught by Linderman, in order to ensure sensing of movements in all directions.
Regarding claim 32, Wagner’s sensing electrodes are designed to be used anywhere on the body, including on a finger.
Regarding claim 36, Wagner further discloses that the third sensing electrode is the negative electromyographic detection electrode (paragraph [0141]).
Regarding claim 40, Wagner further discloses placing a sensing electrode on an index finger of the patient (figure 21B).
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791
