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Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/04/2026.
Applicant’s election without traverse of Invention II, drawn to the method and Group 1, Species A (Figs. 8-8F) a needle guide with a curved base and Group 2, Species A (Fig. 8A) medical element guide with a plurality of slots that does not rotate in the reply filed on 06/04/2026 is acknowledged.
Response to Amendment
This office action is responsive to the amendment filed on 08/04/2026. As directed by the amendment: claims 1-14 have been cancelled. Thus, claims 15-22 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: measuring device in claims 15 and 17.
The claim limitation the “measuring device” invokes 112(f) because the term “device” is a generic placeholder further modified by the functional language “measuring” or “for measuring” and not further modified by sufficient structure. For the purpose of prior art examination this will be interpreted as a “elongated base” or “sliding lateral member” (see [0043] of patent application publication).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 19 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 19 recites the limitation "the apparatus" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination this limitation will be interpreted as “the measuring device”. Appropriate correction is required.
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 15-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 15-22 have been analyzed to determine whether it is directed to any judicial exceptions.
With respect to MPEP 2106.04 step 1, claim 15 is directed to a method (A method, therefore a statutory class) for marking a location on a patient for inserting a needle for placement of a lead for nerve stimulation therapy (intended use).
The following step limitations in independent claim 15:
obtaining a scaled image of a patient
selecting the tip of a patient's coccyx shown in the image
imposing a first line on the image, wherein the first line extends from the tip of the coccyx to a surface of the patient's skin
imposing a second line on the image, wherein the second line extends from the target location perpendicular of the patient's sacrum to the surface of the patient's skin
calculating measurements corresponding to the location on the patient
retrieving the measurements
and marking the patient based on the measurements using a measuring device
Are grouped as a mental process in MPEP 2106.04(a)(2)(III) or mathematical concept in MPEP 2106.04(a)(2)(I). This judicial exception is not integrated into a practical application because:
Is anatomical data gathering/collection, where the data to be analyzed is obtained by the abstract process hence an insignificant extra solution activity, in this case the data obtained, an image it is at a high level of generality such that it can practically be performed in the human mind, as humans are capable of viewing images of human anatomy in order to ascertain relative positioning— a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);
Is a mental process of an abstract idea, which can be done in a person’s mind, finding the coccyx shown in the data gathered in 1. and selecting it, which as with above, a human mind is capable of finding the coccyx in an image whether it be a photograph, CT scan, or an illustration
Is a mental process of an abstract idea, which can be done in a person’s mind or with pen and paper, as a person can reasonably take a picture of the image and visualize or draw a line on the image from one point to another
As with 3. is a mental process of an abstract idea, which can be done in a person’s mind or with pen and paper, a person can reasonably take a picture of the image and visualize or draw a second line on the image from one point to another
Is a mental process of math of an abstract idea, as person with the information above can measure distances
Is anatomical data gathering, where the data to be analyzed is obtained by the abstract process hence an insignificant extra solution activity, in this case this is holding the information from 5.
Are mere instructions to apply in this case, a person can mark the patient with a marker from the data gathered in 5. and 6. furthermore, can be done by a generic computer/tool. Re-evaluating under step 2B, this is furthermore a well-known and routine activity as disclosed by Chieng (US 20170311978 A1) [0027], mark a needle entry point on the skin of the patient corresponding to the intersection of the scan plane and in relation to at least one of the imaged position marker
With respect to MPEP 2106.04 step 1, claim 16 is directed to a method (A method, therefore a statutory class) of claim 15.
The following step limitations in claim 16:
Wherein the method is employed to identify the insertion location for a needle used for lead placement adjacent the S3 foramen of the patient
Is grouped as a mental process in MPEP 2106.04(a)(2)(III). This judicial exception is not integrated into a practical application because:
Are mere instructions to apply in this case, a person can identify the insertion location for a needle adjacent to the S3 foramen of the patient from the data gathered in claim 15, furthermore, can be done by a generic computer/tool. Re-evaluating under step 2B, this is furthermore a well-known and routine activity as disclosed by Chieng (US 20170311978 A1) [0027], mark a needle entry point on the skin of the patient corresponding to the intersection of the scan plane and in relation to at least one of the imaged position marker
With respect to MPEP 2106.04 step 1, claim 17 is directed to a method (A method, therefore a statutory class) of claim 15.
The following step limitations in claim 17:
Wherein measurements include a calculated distance on the measuring device cephalad from the first line
Is grouped as a mental process in MPEP 2106.04(a)(2)(III) or mathematical concept in MPEP 2106.04(a)(2)(I). This judicial exception is not integrated into a practical application because:
Is a mental process of math of an abstract idea, as person with the information above can measure distances respective to a tool
With respect to MPEP 2106.04 step 1, claim 19 is directed to a method (A method, therefore a statutory class) of claim 15.
The following step limitations in claim 19:
Wherein measurements include a needle entry angle, wherein the calculation of the needle entry angle is derived from the second line and a line tangent to the are length of the apparatus
Is grouped as a mental process in MPEP 2106.04(a)(2)(III) or mathematical concept in MPEP 2106.04(a)(2)(I). This judicial exception is not integrated into a practical application because:
Is a mental process of math of an abstract idea, as person with the information above can measure distances and calculate an angle respective to a tool
With respect to MPEP 2106.04 step 1, claim 21 is directed to a method (A method, therefore a statutory class) of claim 15.
The following step limitations in claim 21:
Wherein at least one of the steps of imposing the first line and imposing the second line is accomplished using Al based on image recognition
Is grouped as a mental process in MPEP 2106.04(a)(2)(III) or mathematical concept in MPEP 2106.04(a)(2)(I). This judicial exception is not integrated into a practical application because:
Is a mental process done with a generic computer tool (AI), Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the first line and second line being imposed using AI based on image recognition (see [0028], of patent application publication, which merely asserts that machine learning or AI can be used in order to provide enhanced image recognition capabilities without addressed specialized programming or algorithms, hence essentially admitting this hardware is convention). This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I))
With respect to MPEP 2106.04 step 1, claim 22 is directed to a method (A method, therefore a statutory class) of claim 21.
The following step limitations in claim 22:
Wherein the imposing steps are accomplished without regard to the orientation of the patient on the image
Is grouped as a mental process in MPEP 2106.04(a)(2)(III) or mathematical concept in MPEP 2106.04(a)(2)(I). This judicial exception is not integrated into a practical application because:
Is a mental process done with a generic computer tool (AI)
Claims 15-17, 19, and 21-22 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the reasons set forth above. Hence claims 15-22 are not patent eligible and are rejected under 35 U.S.C. 101. Claims 18 and 20 are rejected as being dependent on claim 15.
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.
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) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crites-Bachert (US 20200008762 A1), herein referenced to as “Crites-Bachert” in view of Stetz et al (US 20080039866 A1), herein referenced to as “Stetz”.
Claim 15
Crites-Bachert discloses: A method (see Figs. 3-9, [0036]) for marking a location on a patient (see [0036]) for inserting a needle for placement of a lead for nerve stimulation therapy (see [0036], needle positioning and lead implantation), the method includes the steps of: obtaining a scaled image of a patient (see Figs. 3-4, [0038]-[0040], fluoroscopic image on a computer monitor, which is a scaled image from physical patient features to a computer monitor); selecting the tip of a patient's coccyx shown in the image (see Figs. 3-4 and 9, [0038], the line 32 extends through the patient’s coccyx as it is a midline that extends through the sacrum vertically, hence it extends through the coccyx, thus selecting the coccyx); imposing a first line on the image (see Figs. 3-4 and 9, [0038]), wherein the first line extends from the tip of the coccyx to a surface of the patient's skin (see Figs. 3-4 and 9, [0038], the line 32 extends through the patient’s coccyx as it is a midline that extends through the sacrum vertically, hence it extends through the coccyx, thus selecting the coccyx, notes that the line 32 can be adjacent to the skin hence extending on the surface of the patient’s skin as well); imposing a second line on the image 34 (see annotated Fig. 4 below, [0039] and [0045]), wherein the second line extends from the target location perpendicular of the patient's sacrum to the surface of the patient's skin (see annotated Fig. 4 below); calculating measurements corresponding to the location on the patient (see Figs. 3-4 and 9, [0045], measurement respective of the location is determined, 1 cm); retrieving the measurements (see [0045], measurements of the anatomy as indicated by the liens).
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Crites-Bachert does not explicitly disclose: marking the patient based on the measurements using a measuring device.
However, Stetz in a similar field of invention teaches a method for marking a location on a patient (see [0026]) for inserting a needle (see [0010], needle) for placement of a lead (see [0026], medical lead, electrical stimulator) for nerve stimulation therapy and calculating measurements corresponding to the location on the patient (see Figs. 3-5 and 8A-9). Stetz further teaches: marking (see [0091], markers) the patient based on the measurements (see Figs. 3-5 and 8A-9, [0091]-[0096], locate a target nerve site, with associate reference markers) using a measuring device 150 (see Figs. 8A-9, [0091], meets the 112(f) interpretation of an elongated base).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Crites-Bachert to incorporate the teachings of Stetz and teach a method for marking a location on a patient with marking the patient based on the measurements using a measuring device. Motivation for such can be found in Stetz as the measuring device can serve as a physical guide to target a nerve site and to accessing the target nerve site in addition to medical imaging (see [0096]).
Claim 16
The combination of Crites-Bachert and Stetz teaches: The method of claim 15, see 103 rejection above. Crites-Bachert further discloses: wherein the method is employed to identify the insertion location for a needle 26 used for lead placement adjacent the S3 foramen of the patient (see Figs. 4-5, [0035] and [0045]-[0047], sacral #3 foramen).
Claim 17
The combination of Crites-Bachert and Stetz teaches: The method of claim 15, see 103 rejection above. The combination of Crites-Bachert and Stetz further teaches: wherein measurements include a calculated distance on the measuring device cephalad from the first line (as combined, the midline first distance would extend cephalad across the measuring device, which is upwards/ towards 124a on 150).
Claim 18
The combination of Crites-Bachert and Stetz teaches: The method of claim 17, see 103 rejection above. Crites-Bachert further discloses: further comprising inserting the needle 26 into the patient at the location to a patient's foramen (see Figs. 4-5, [0035] and [0045]-[0047], the needle is inserted into the S3 foramen).
Claim 19
The combination of Crites-Bachert and Stetz teaches: The method of claim 15, see 103 rejection above. The combination of Crites-Bachert and Stetz further teaches: wherein measurements include a needle entry angle (see [0007]-[0008], needle angle is varied), wherein the calculation of the needle entry angle is derived from the second line and a line tangent to the are length of the apparatus (see [0035] and [0045]-[0047], the calculation of the needle angle is based on the second line and the medial line, which is along the length of the device as modified with Stetz).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crites-Bachert and Stetz as applied to claim 15 above, and further in view of Chieng et al (US 20170311978 A1), herein referenced to as “Chieng”.
Claim 20
The combination of Crites-Bachert and Stetz teaches: The method of claim 15, see 103 rejection above. Stetz further teaches: wherein the measuring device 150 includes an elongate base 150, having a first set of indicia 128 (see Fig. 6A-8A, [0072]), configured to extend longitudinally across the patient's back (see [0072] and [0074], longitudinally across the back and in relation to 22) and lay adjacent to the patient's coccyx 22 (124B extends across the sacrum/coccyx) and a lateral member 126a + 126b (see Figs. 6A-8A [0072]), having a second set of indicia 130 (see Figs. 6A-8A, [0072]).
The combination of Crites-Bachert and Stetz does not explicitly teach: the lateral member slidably attached to the elongate base.
However, Chieng in a similar field of invention teaches a method for marking a location on a patient for inserting a needle (see Figs. 1-23) with an elongate base 1 (see Figs. 1-23) and a lateral member 2 + 3 (see Figs. 1-23). Chieng further teaches: the lateral member 2 + 3 slidably attached ([0063], 2/2a + 3 can extend and move in relation to 1 to change the angle of the needle/introducer) to the elongate base 1.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Crites-Bachert and Stetz to incorporate the teachings of Chieng and teach a method for marking a location on a patient with the lateral member slidably attached to the elongate base. Motivation for such can be found in Chieng as this as allows for degrees of movement along different planes while locking in place to prevent arcs from moving when inserting the needle (see [0065]).
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crites-Bachert and Stetz as applied to claim 15 above, and further in view of Alanay et al (US 20220142562 A1), herein referenced to as “Alanay”.
Claim 21
The combination of Crites-Bachert and Stetz teaches: The method of claim 15, see 103 rejection above. The combination of Crites-Bachert and Stetz does not explicitly teach: wherein at least one of the steps of imposing the first line and imposing the second line is accomplished using Al based on image recognition.
However, Alanay in a similar field of invention teaches a method for marking a location on a patient (see Figs. 1-7) with imposing a first line and a second line on an image (see Figs. 1-7, [0091]). Alanay further teaches: wherein at least one of the steps of imposing the first line and imposing the second line (see Figs. 1-7, [0091]) is accomplished using Al based on image recognition (see [0091] and [0108], deep learning algorithms).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Crites-Bachert to incorporate the teachings of Alanay and teach a method for marking a location on a patient with at least one of the steps of imposing the first line and imposing the second line is accomplished using Al based on image recognition. Motivation for such can be found in Alanay as this can be used to automatically detect sacrum and using deep learning can improve accuracy as new radiographs are uploaded, decreasing the margin of error (see [0108]).
Claim 22
The combination of Crites-Bachert, Stetz, and Alanay teaches: The method of claim 15, see 103 rejection above. Crites-Bachert further discloses: wherein the imposing steps are accomplished without regard to the orientation of the patient on the image (see [0011]-[0022], the imposing of the lines are done on both anterior/posterior views and lateral views, hence without regard to the orientation of the patient on the image).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cragg (US 20070055260 A1) teaches a method for marking a location on a patient with imposing a line from the tip of the coccyx to a surface of the patient’s skin (see Figs. 23-24)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/ Examiner, Art Unit 3771
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