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
Claims 1-10 and 18-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention I, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 27, 2025.
Applicant's election with traverse of invention II in the reply filed on October 27, 2025 is acknowledged. The traversal is on the grounds that inventions that are independent or distinct is contradictory to them also being related, and also on the grounds that the apparatus of claim 11 cannot be used in materially a different process as claimed. This is not found persuasive because MPEP 806(B) recites that where inventions are related as disclosed (localized acupoint microdosing) but are distinct as claimed (method and system), restriction may be proper. Additionally, the system claims are rejected below under 35 U.S.C. 112(b) below because they include method steps, and for purposes of examination, the method steps are interpreted functionally such that the system may be used in a materially different process as noted in the restriction mailed August 27, 2025.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 101
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 11-17 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).
This §101 rejection is being made due to a lack of clarity, because it is not entirely clear if certain limitations (mapping basis, target area, treatment point) encompass a human organism and are therefore not subject matter eligible, or instead if claimed method steps should be interpreted as functional limitations of the system. For purposes of examination, see the112(b) rejections below. If instead, Applicant intended the subject matter to encompass a human organism, then this 35 U.S.C. §101 rejection is applicable.
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.
Claims 11-17 are 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 11 line 3 recites “…a medical condition…”. It is not clear if this is the same medical condition of lines 1-2. For purposes of examination, this is interpreted as “…the medical condition..”. Claims 12-17 are rejected at least because they depend from claim 11.
Claim 11 lines 3-9 recite “…a mapping basis corresponding to a medical condition to be treated; a target area for treatment defined relative to the mapping basis; a treatment point identified within the target area; and a treatment dose of medically approved toxin injected into the treatment point…”. MPEP 2173.05(p)(II) recites a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. Here, claim 11 claims both an apparatus (system) and method steps for use of the system (injected as claimed), and is therefore indefinite. Recited structure includes a treatment dose of medically approved toxin, and the method step includes injection as claimed. For purposes of examination, the claim is interpreted “…a treatment dose of medically approved toxin configured to be injected into a treatment point identified within a target area defined relative to a mapping basis corresponding to the medical condition to be treated…”. Claims 12-17 are rejected at least because they depend from claim 11.
Claim 11 line 8 recites “…a treatment dose…”. It is not clear what quantity or concentration of toxin is required for a treatment dose. For purposes of examination, this is interpreted as “…a dose…”.
Claim 11 line 8 recites “…medically approved toxin…”. It is not clear which medical authority approved the toxin, and one may argue that any use is de facto medically approved. For purposes of examination, this is interpreted to mean any toxin that is used medically. Claims 12-17 are rejected at least because they depend from claim 11.
Claim 14 lines 2-3 recite “…injected into the treatment point with a 30-gauge, or smaller, needle…”, which is a method step. For purposes of examination, this is interpreted as “…configured to be injected into the treatment point with a 30-gauge, or smaller, needle…”.
Claim 14 line 3 recites “…a 30-gauge, or smaller, needle…”. A lower gauge number is thicker. It is not clear if the claimed smaller needle in less than the number 30 in which case a thicker needle is claimed having a gauge less than 30, or if the smaller needle is a thinner needle having a gauge greater than 30. For purposes of examination, smaller is interpreted to be a gauge less than 30.
Claim 15 recites “…wherein the treatment dose…comprises a treatment dose of less than or equal to 1/50th of 1 unit of medically approved toxin…”. It is not clear if this is in reference to an amount or concentration. For purposes of examination, this is interpreted as an amount.
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.
Claims 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lamb 6,806,251.
Regarding claim 11, Lamb discloses a system for localized acupoint microdosing treatment of a medical condition (this is being interpreted as a mere statement of purpose or use, see MPEP 2111.02, that does not result in a structural difference to the system), comprising: a mapping basis (back pain or spinal pain, c 1 ln 15-16) corresponding to a medical condition to be treated (intrinsic spinal muscle disfunction, 2 ln 8); a target area (deep intrinsic spinal muscle, c 3 ln 57) for treatment defined relative to the mapping basis; a treatment point (multifidus, rotator brevis and longus muscles, c 3 ln 66 to c 4 ln 1) identified within the target area; and a treatment dose of medically approved toxin (botulinum toxin, c 2 ln 33) injected into the treatment point (the reference satisfies this limitation once the toxin has been injected, c 3 ln 67).
Regarding claim 12, Lamb discloses the system of claim 11, wherein the mapping basis comprises one or more traditional acupuncture points (the botulinum toxin is fully capable of being injected into a treatment point identified within a target area defined relative to one or more traditional acupuncture points corresponding to the medical condition to be treated).
Regarding claim 13, Lamb discloses the system of claim 11, wherein a plurality of treatment points are identified within the target area (the botulinum toxin is fully capable of being injected into a plurality of treatment points identified within a target area defined relative to a mapping basis corresponding to the medical condition to be treated).
Regarding claim 14, Lamb discloses the system of claim 11, wherein the treatment dose of medically approved toxin is injected into the treatment point with a 30-gauge, or smaller, needle (the botulinum toxin is fully capable of being injected into a treatment point with a 30-gauge, or smaller, needle identified within a target area defined relative to a mapping basis corresponding to the medical condition to be treated because Lamb teaches use of 20-25 gauge needles c 5 ln 53-54).
Regarding claim 15, Lamb discloses the system of claim 11, wherein the treatment dose of medically approved toxin comprises (see MPEP 2111.03 regarding the transitional phrase comprising, which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements) treatment dose of less than or equal to 1/50th of 1 unit of medically approved toxin (Lamb, 1-20 MU of Botulinum toxin, c 4 ln 1-2).
Regarding claim 16, Lamb discloses the system of claim 11, wherein the medical condition is Parkinson's disease (the system of Lamb is fully capable of being used to treat Parkinson’s disease because the system includes the claimed toxin).
Regarding claim 17, Lamb discloses the system of claim 11, wherein the medical condition is dementia (the system of Lamb is fully capable of being used to treat dementia because the system includes the claimed toxin).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783