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 1-23 have been canceled, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/24/2026.
Applicant’s election without traverse of Invention I, Species C (it is noted applicant appears to have made a typographical error in selecting Species D, as applicant goes on to recite new claims 24-26 are drawn to the elected invention of Figs. 8H-8I and paragraph [0052], which pertains to Species C, not D) in the reply filed on 7/24/2026 is acknowledged.
Claim Objections
Claim 23 is objected to because of the following informalities: Claim 23 recites “the base” in line 4 which should read “the elongated base” for consistency purposes. Appropriate correction is required.
Claims 24-26 are objected to because they depend from canceled claim 22. For the purposes of examination, the claims are interpreted to depend from independent claim 23.
Claim 26 is objected to because of the following informalities: Claim 26 recites “the monolithic member” in lines 1 and 2-3 which should read “the lateral member” for consistency purposes. Appropriate correction is required.
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: a locking mechanism in claim 26.
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 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.
Claim 26 is 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.
Claim 26 recites “the monolithic member includes a locking mechanism” in lines 1-2. By definition, the monolithic member is a “one-piece” structure. The claimed “locking mechanism” is interpreted under 112(f) to be “a thumb screw or other conventional or later developed locking mechanism that may be used to selectively lock (e.g., prevent) and unlock (e.g., permit) the translational movement of one device sliding along another device” ([0043]) as the locking mechanism 845’ present in the monolithic lateral member 815’ functions similarly to the locking mechanism as described previously in other embodiments ([0052]). A thumb screw inherently must rotate relative to the monolithic lateral member 815’ in order to lock and unlock the position of the lateral member 815’ on the elongated base 810. Therefore, a thumb screw cannot be a part of the one-piece monolithic member as required by claim 26. Accordingly, 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. For the purposes of examination, the limitation has been interpreted to read “wherein the apparatus includes a locking mechanism configured to selectively prevent or permit translation movement of the monolithic member relative to the elongated base.”
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 23-26 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 23 recites the limitation "the target location" in line 10. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura (US 2020/0121287 A1) in view of Sahni (US 2011/0190787 A1).
Regarding claims 23 and 26, Nakamura discloses an apparatus (medical guidance apparatus 2000; Fig. 5A) for guiding insertion of a needle into a patient receiving sacral nerve stimulation therapy (as the apparatus 2000 is used for guiding needles into a patient; [0014]), the apparatus comprising: an elongated base (including base assembly 2110 and guide 2150, which includes an elongated arch member 2154; Fig. 5A) having a first set of indicia (illumination indicators 2174a, 2174b), configured to extend longitudinally along the back of the patient (as arc member 2154 may be placed by a user so as to extend longitudinally along the back of a patient) and, wherein the base is configured to lay adjacent to and be pressed against the coccyx of the patient (as 2110 may be placed and pressed by a user against the coccyx of the patient); a laterally extending member (instrument holder 2157) slidably attached to the elongate base (2157 may be slidable along the rail 2155 of arc member 2154; [0073]); and wherein the lateral member (2157) includes a plurality of guide slots (while only one half cylindrical groove sized to receive a needle 2161 is shown, the instrument holder 2157 may be shaped to fit multiple instruments in a pre-set geometric configuration i.e., two needles may be held simultaneously, both positioned near tangential to the arc member 2154; [0073]; [0074]; thus, 2157 may contain multiple slots for two or more needles) located a fixed distance from the elongated base (as the slot(s) are fixed laterally from the arc member 2154; Fig. 5A), wherein each of the guide slots (half cylindrical grooves) are configured to aid the insertion of the needle into the patient at a predetermined angle at the target location ([0073]-[0074]).
Nakamura fails to explicitly disclose wherein the lateral member is a one-piece monolithic member, wherein the lateral member includes a second set of indicia, and a locking mechanism configured to selectively prevent or permit translation movement of the monolithic member relative to the elongated base.
However, Nakamura teaches it was known to include differentiating markers shown as different colors or hues located on surfaces of the apparatus which are visible during use to differentiate the portion of the medical guidance apparatus, device or system where the needle with be placed and guided. The differentiating marker may be, for example, a different color, an adhesive, a pattern, or some other differentiator that the physician or clinician can use to quickly differentiate which portion of the device should be used during needle placement ([0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lateral member of Nakamura to include differentiating markers i.e., a second set of indicia in light of the teachings of Nakamura in order to differentiate between the plurality of guide slots to allow the physician or clinician to quickly differentiate which slot the needle should be inserted during use.
Modified Nakamura fails to explicitly disclose wherein the lateral member is a one-piece monolithic member, and a locking mechanism configured to selectively prevent or permit translation movement of the monolithic member relative to the elongated base.
However, Sahni teaches an apparatus (Fig. 1) for guiding insertion of a needle into a patient (needle placement device; Fig. 1; abstract), the apparatus comprising: an elongated base (including at least base plate 1 and falling arc 3) having a first set of indicia (indicia on arc 3; Fig. 1); a laterally extending one-piece monolithic member (needle guide 6 which is of one-piece construction; Figs. 1, 9-10) slidably attached to the elongate base (as 6 slides on the superior surface of the arc 3; abstract), wherein the lateral member includes a guide slot (wedge shaped needle track 32) located a fixed distance from the elongated base (as 32 is a fixed distance from arc 3; Fig. 1), wherein the guide slot (32) is configured to aid the insertion of the needle into the patient at a predetermined angle at the target location (Fig. 1); and a locking mechanism (interpreted under 112(f) as a thumb screw and equivalents thereof as discussed in paragraphs [0043]; [0052] of applicant’s specification and Sahni discloses the needle guide 6 includes a hole 36 for a screw to fix the needle guide 6 to the arc blade 19; [0032]) configured to selectively prevent or permit translation movement of the monolithic member (6) relative to the elongated base ([0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lateral member of modified Nakamura to be a one-piece monolithic member with a hole for a screw as taught by Sahni, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893). Further, the hole/screw configuration taught by Shani would allow the lateral member to be selectively locked and unlocked relative to the elongated base/arc to improve stability and accuracy of placement of the needle when in use.
Regarding claim 24, Nakamura modified fails to disclose wherein the fixed distance is 22 mm.
However, Nakamura teaches the fixed distance is based on the width of lateral member (2157; Fig. 5A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixed distance of modified Nakamura to be 22 mm i.e., the width of the lateral member to be 22 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the apparatus of modified Nakamura would not operate differently with the claimed fixed distance since the needle of Nakamura is already spaced a distance from the arc of the elongated base and the apparatus would function appropriately having a lateral member with a width of 22 mm. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the fixed distance “may be approximately” within the claimed range (specification [0052]).
Regarding claim 25, Nakamura modified discloses the invention as claimed above, and Nakamura further discloses wherein the guide slots (2157) are configured for use with the needle (2161) by being sized for a snap fit with the needle (as 2157 is in the shape of a half cylindrical groove sized to receive a needle; [0073]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Frey et al. (US 2025/010883 A1) is noted for teaching a lateral member with multiple guide slots. Shakuri-Rad et al. (US 2023/0329750 A1) is noted for teaching a needle guide for a coccyx. Bouazza-Marouf et al. (US 2019/0282262 A1) is noted for teaching a lateral member at a fixed distance from a base. Miller et al. (US 5,758,650) and Wung et al. (US 5,623,931) are noted for teaching a lateral member with multiple guide slots.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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