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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/9/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 is/are amended and claim(s) 13-26 is/are canceled and claim 2 was previously canceled. Claims 1 and 3-12 are now pending examination.
Response to Arguments
Applicant’s arguments, filed 3/16/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Examiner agrees the added limitation “laterally positioning a medical element guide of the guide device relative to a head of the guide device based on the determined lateral distance” overcomes the previous rejection as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Stetz in view of Bonde.
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: “locating element” in claim 4.
Claim 4 recites the limitation of a “a locating element”. The term “element” is used as a substitute for “means” and is modified by functional language “locating”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “a locating element” is “a disc or other shaped structure that is affixed to the patient during the imaging” (Paragraph 0052) or equivalents thereof.
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.
Claims 1 and 3-12 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 1 recites the limitation "the determined lateral distance" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation will be seen as “a determined lateral distance”.
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) 1-2 and 4-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stetz et al. (US 20080039866 A1) (noted on IDS) in view of Bonde et al. (US 20080300491 A1) (previously of record) in view of Li et al. (CN 113952006 A) (in text references correspond with attached Espacenet translation).
Regarding claim 1, Stetz discloses a method, comprising:
determining one or more measurements from at least one image of a sacrum (22) of a patient (18) (Paragraph 0009; 0031; 0033; 0046; 0056) (Stetz discloses “The clinician may then register the relevant portions of the medical image, such as the reference markers associated with the target tissue site and/or the target tissue site image, to an actual location on or within the patient.” As such, the clinician uses measurements from the reference markers in the image to determine the associated location of target tissue in a patient. Further, “locating guide 30 may include labeled distance markers 34, 36, 42, 44 to indicate distance and/or provide a visual reference marker,” thus providing one or more measurements. Further, the measurements can include a lateral distance.);
applying the determined one or more measurements with a guide device (30) (Paragraph 0009; 0033; 0035; 0056) (Stetz states “Based on the image, for example, the clinician may determine the magnitude and direction in which locating guide 30 should be moved in order to align centerline markers 38 with the crest of Ilium bone 62 and centerline markers 46 with spinal canal 66. The clinician may then reposition locating guide 30 accordingly.”, thus using the information from markings on the image, the clinician adjusts the guide 30, hence applying the determined measurements with a guide device.);
wherein the guide device is adjustable (Paragraph 0038; 0056; 0064) and applying the determined one or more measurements with the guide device comprises adjusting the guide device based on the one or more measurements (Paragraph 0056 states “Based on the image, for example, the clinician may determine the magnitude and direction in which locating guide 30 should be moved in order to align centerline markers 38 with the crest of Ilium bone 62 and centerline markers 46 with spinal canal 66. The clinician may then reposition locating guide 30 accordingly.”, thus the clinician adjusts the guide device based on measurements from the image.) (Paragraph 0056; 0064; 0097)
locating the guide device on the patient's backside using a landmark (boney landmark and/or reference markers) (Paragraph 0032-33); and
while the guide device is located on the patient's backside, using the guide device to guide insertion of a medical element (introducer needle) into the patient (Paragraph 0010; 0059).
Stetz fails to explicitly disclose applying the determined one or more measurements comprises translationally adjusting elements of the guide device relative to each other based on the one or more measurements including laterally positioning a medical element guide of the guide device relative to a head of the guide device based on the determined lateral distance.
However, Bonde is directed to a guide device (30) wherein the guide device is adjustable (Paragraph 0029; 0038) and applying the determined one or more measurements comprises translationally adjusting elements (adjustment mechanism, i.e., knob 354, joining structure 33, body of guide 30, Paragraph 0031-0032) of the guide device relative to each other based on the one or more measurements (Figure 3B; Paragraph 0030; 0038; 0040). (Based on measurements taken from scanning device 100, different components of the needle guide are adjusted to correspond to the correct location on the patient).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of Stetz such that applying the determined one or more measurements comprises translationally adjusting elements of the guide device relative to each other based on the one or more measurements, as taught by Bonde, as both references and the claimed invention are directed to guide devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stetz with the teachings of Bonde by incorporating applying the determined one or more measurements comprises translationally adjusting elements of the guide device relative to each other based on the one or more measurements in order to properly reposition the device according to the anatomy of the patient.
Further, Li teaches laterally positioning a medical element guide (22) of the guide device relative to a head (1) of the guide device based on the determined lateral distance (Figure 1; Paragraph 0029; 0032; 0037) (Based on the distances calculated by Li, the device is moved according to the corresponding scale lines. Further, as a result of the modification, one of ordinary skill in the art would use the determined measurements from Stetz, and could apply the step of positioning the medical guide element according to those determined measurements).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Stetz as modified by Bonde to include a medical element guide on the body of Stetz’s device and laterally positioning a medical element guide of the guide device relative to a head of the guide device based on the determined lateral distance, as taught by Li, as both references and the claimed invention are directed to surgical guide devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stetz as modified by Bonde with the teachings of Li by incorporating laterally positioning a medical element guide of the guide device relative to a head of the guide device based on the determined lateral distance in order to assist the user in indicating a desired position and stabilizing the medical element in place.
Regarding claim 4, Stetz further discloses wherein the landmark comprises a locating element (38, 40, 46, 48) affixed to the patient (the locating guide 30 comprises centerline and lateral markers, which are “shaped structures” and the guide and is affixed to the patient, thus the markers are also affixed to the patient) (Paragraph 0048-49).
Regarding claim 5, Stetz further discloses wherein the at least one image comprises an image of a pelvis of the patient in a lateral plane (Figure 1; Paragraph 0064; Paragraph 0103).
Regarding claim 6, Stetz further discloses wherein the at least one image comprises an image of the pelvis of the patient in an anterior posterior plane (Paragraph 0064).
Regarding claim7, Stetz further discloses wherein the at least one image comprises an X-ray (Paragraph 0031) (Stetz states the medical imaging device may be an x-ray machine, thus producing an x-ray image.).
Regarding claim 8, Stetz further discloses wherein the one or more measurements are determined based on user input defining points (reference point) of interest in the at least one image (Paragraph 0068-69).
Regarding claim 9, Stetz further discloses wherein the points of interest in the at least one image comprise a location of a foramen (70) in the sacrum (Paragraph 0059; 0069).
Regarding claim 10, Stetz further discloses wherein the one or more measurements are determined based on a predefined dimension (reference markers) of the guide device (Paragraph 0062).
Regarding claim 11, Stetz further discloses wherein the guide device on the patient's backside defines a location and an angle of entry of the medical element into the patient's body (Paragraph 0093).
Regarding claim 12, Stetz further discloses wherein the medical element comprises a needle (Paragraph 0059).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stetz in view of Bonde and Li and further in view of Navis (US 6589212 B1) (previously of record).
Regarding claim 3, Stetz as modified by Bonde and Li discloses the method of claim 1, and discloses wherein the landmark is a boney landmark located on a patient’s back (Paragraph 0058), but fails to explicitly disclose wherein the landmark comprises the patient's coccyx.
However, Navis is directed to a surgical guide method and teaches inserting a needle using a coccyx as a visual landmark (Col 9, line 22-25; 34-36; 48-41).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Stetz as modified by Bonde and Li such that the landmark comprises the patient's coccyx, as taught by Navis, as both references and the claimed invention are directed to spinal access methods. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stetz as modified by Bonde and Li with the teachings of Navis by incorporating wherein the landmark comprises the patient's coccyx in order to guide needle insertion near the coccyx., and Stetz is silent to which bone specifically is referred to as a boney landmark.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 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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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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