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 Species I in the reply filed on 01/28/2026 is acknowledged.
Claims 5-8 & 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/28/2026.
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 as follows.
“signal mechanism” in Claim 2, where the generic placeholder is “mechanism”, the functional language is “provide the output to the user”, and sufficient modifying structure is not provided; the instant application fails to provide sufficient modifying structure for the claimed light or sound generating mechanism
“light or sound generating mechanism” in Claim 2, where the generic placeholder is “mechanism”, the functional language is “light or sound generating”, and sufficient modifying structure is not provided; the instant application fails to provide sufficient modifying structure for the claimed light or sound generating mechanism
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 2 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.
As to Claim 2, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a signal mechanism. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe a signal mechanism.
The only mention of a mechanism within the context of being capable of outputting a signal to a user is in Paragraph 0080. However, no structure is provided for the mechanism. As such, the original disclosure lacks sufficient written description for the claimed light- or sound-generating mechanism.
Applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims a light- or sound-generating mechanism. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately describe a light- or sound-generating mechanism.
The only mention of a mechanism within the context of being capable of generating light or sound is in Paragraph 0080. However, no structure is provided for the mechanism. As such, the original disclosure lacks sufficient written description for the claimed light- or sound-generating mechanism.
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 2 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.
As to Claim 2, the term “signal mechanism” is indefinite. As described in the 112(a) rejection above, the term lacks sufficient written description. As such, it is not clear how the output is being provided to the user, rendering the claim indefinite.
The term “a light- or sound-generating mechanism” is indefinite. As described in the 112(a) rejection above, the term lacks sufficient written description. As such, it is not clear how light or sound is being generated, rendering the claim indefinite.
Additionally, the term should be written as --a light[[-]] or sound[[-]] generating mechanism.
The terms “an output” and “a user”, in Lines 4, are indefinite. An output and a user were previously defined in Claim 1, Line 8. As such, it is not clear if a second output or second user are being defined in Claim 2, or if the output and user of Claim 2 is the same output and user as Claim 1. For the purpose of examination, the output and user of Claim 2 will be interpreted as the same output and user of Claim 1.
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 1-4, 9-10 & 18-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berndt (U.S. PGPub 2014/0135630).
As to Claim 1, Berndt teaches an injection apparatus (11), comprising: a needle (41) configured to be inserted into a tissue (Paragraph 0042);
a light source (15) to deliver light to the tissue (Paragraph 0042) to generate reflected light (Paragraph 0042);
a detector (17) to detect the reflected light from the tissue (Paragraph 0042); and
a processor (19) coupled to (as shown in Figure 2) the detector (17) and configured to:
analyze the reflected light from the tissue (Paragraph 0042) to identify a tissue type associated with (Paragraph 0041) the reflected light (Paragraph 0042), and
provide an output (visual, aural, etc.; Paragraph 0042; or lights/audio; Paragraph 0042) to a user (“one”, as indicated in Paragraph 0042) based on the identified tissue type (Paragraphs 0041/0042).
As to Claim 2, Berndt teaches all the limitations of Claim 1, and continues to teach a signal mechanism (21) including at least one of a light- or sound-generating mechanism (lights/audio; Paragraph 0042), and
wherein the processor (19), when providing an output (lights/audio; Paragraph 0042) to a user (“one”, as indicated in Paragraph 0042) based on the identified tissue type (Paragraph 0041), is further configured to:
provide the output (lights/audio; Paragraph 0042) to the user (“one”, as indicated in Paragraph 0042 using the signal mechanism (21) based on the identified tissue type (Paragraph 0041).
As to Claim 3, Berndt teaches all the limitations of Claim 1, and continues to teach a detector waveguide (49-1) associated with (Paragraph 0030) the needle (41) and optically coupled to (via connector 55-1; Paragraphs 0030/0041) the detector (17), wherein the detector waveguide (49-1) is configured to transmit the reflected light from the tissue to (Paragraph 0042) the detector (17).
As to Claim 4, Berndt teaches all the limitations of Claims 1 & 3, and continues to teach a source waveguide (49-2) associated with (Paragraph 0030) the needle (41) and optically coupled to (via connector 55-2; Paragraphs 0030/0040) the light source (15), wherein the source waveguide (49-2) is configured to transmit light from (Paragraph 0042) the light source (15) to the tissue (Paragraph 0042).
As to Claim 9, Berndt teaches all the limitations of Claims 1 & 3-4, and continues to teach the detector waveguide (49-1) is adjacent to (as shown in Figure 4) the source waveguide (49-2).
As to Claim 10, Berndt teaches all the limitations of Claims 1 & 3-4, and continues to teach the detector waveguide (49-1) comprises an optical fiber (Paragraph 0030).
As to Claim 18, Berndt teaches all the limitations of Claim 1, and continues to teach the needle (41) is between 23 gauge and 30 gauge (Paragraph 0029 describes needle 41 as being 25 gauge).
As to Claim 19, Berndt teaches all the limitations of Claim 1, and continues to teach the needle (41) is disposed within (as shown in Figure 3) a cannula (61).
As to Claim 20, Berndt teaches all the limitations of Claim 1, and continues to teach the apparatus (11) is a standalone device (as shown in Figure 2).
As to Claim 21, Berndt teaches all the limitations of Claim 1, and continues to teach a hub (81) and a flange (111/121),
wherein the needle (41), the light source (15), and the detector (17) are associated with (as shown in Figure 4, where each structure of the injection apparatus 11 is broadly associated with every other structure of the injection apparatus) the hub (81), and
wherein the processor (19) is associated with (as shown in Figure 4, where each structure of the injection apparatus 11 is broadly associated with every other structure of the injection apparatus) the flange (111/121).
As to Claim 22, Berndt teaches all the limitations of Claims 1 & 22, and continues to teach the hub (81) is detachably (see end of paragraph for clarification) connected to (as shown in Figure 4) the flange (111/121). Although Paragraph 0036 states the insertion of barb 121 through aperture 104 results in stem portion 112 not “easily” withdrawn through aperture, this does not mean barb 121 cannot be withdrawn, and one of ordinary skill in the art would conclude barb 121 may be withdrawn in a difficult manner, resulting in hub 81 being detached from flange 111/121.
As to Claim 23, Berndt teaches all the limitations of Claim 1, and continues to teach a hub (81) and a flange (111/121),
wherein the needle (41) is associated with (as shown in Figure 4, where each structure of the injection apparatus 11 is broadly associated with every other structure of the injection apparatus) the hub (81), and
wherein the light source (15), the detector (17), and the processor (19) are associated with (as shown in Figure 4, where each structure of the injection apparatus 11 is broadly associated with every other structure of the injection apparatus) the flange (111/121).
As to Claim 24, Berndt teaches all the limitations of Claims 1 & 23, and continues to teach the hub (81) is detachably (see end of paragraph for clarification) connected to (as shown in Figure 4) the flange (111/121). Although Paragraph 0036 states the insertion of barb 121 through aperture 104 results in stem portion 112 not “easily” withdrawn through aperture, this does not mean barb 121 cannot be withdrawn, and one of ordinary skill in the art would conclude barb 121 may be withdrawn in a difficult manner, resulting in hub 81 being detached from flange 111/121.
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.
Claims 13 & 25 are rejected under 35 U.S.C. 103 as being unpatentable over Berndt, in view of Fischer (U.S. Patent 5,944,698).
As to Claim 13, Berndt teaches all the limitations of Claim 1, and continues to teach the needle (41) is coupled to a syringe (Paragraph 0042) containing an injection material (the solution, which may be therapeutic agents or implants, as described in Paragraph 0029).
Berndt describes attaching a syringe to threads 143 in Figure 4, but does not describe the syringe, so does not explicitly teach a syringe barrel containing an injection material,
wherein the syringe barrel has a plunger disposed therein.
Fischer describes a syringe with a threaded distal end (66), and teaches a syringe barrel (12) containing (Column 5, Lines 17-24) an injection material (the fluid in fluid reservoir 24, as described in Column 5, Lines 17-24),
wherein the syringe barrel (12) has a plunger (14) disposed therein (as shown in Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the syringe, as taught by Fischer, in place of the syringe, as taught by Berndt, to deliver “fluid a drop at a time in response to a little amount of force within a range of forces that can be manually applied to the plunger of the syringe (Column 2, Lines 49-52).”
Modifying the Fischer syringe into the Berndt injection apparatus, results in movement (Fischer Column 5, Lines 25-39) of the plunger (Fischer 14) into the barrel (Fischer 12) forces (Berndt Paragraph 0042) the injection material (the Berndt solution, which may be therapeutic agents or implants, as described in Berndt Paragraph 0029) through (via Berndt 141/137/127/122/67/47, as described in Berndt Paragraph 0042) a distal tip (Berndt 45) of the needle (Berndt 41) into the tissue (Berndt Paragraph 0042).
As to Claim 25, Berndt teaches all the limitations of Claim 1, and continues to teach the needle (41) is coupled to (via 71/81/111/143) a syringe (Paragraph 0042) barrel with a plunger disposed therein, and
wherein the plunger is withdrawn to draw fluid from the tissue through the needle.
Berndt describes attaching a syringe to threads 143 in Figure 4, but does not describe the syringe, so does not explicitly teach a syringe barrel with a plunger disposed therein, and
wherein the plunger is withdrawn to draw fluid from the tissue through the needle.
Fischer describes a syringe with a threaded distal end (66), and teaches a syringe barrel (12) with a plunger (14) disposed therein (as shown in Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the syringe, as taught by Fischer, in place of the syringe, as taught by Berndt, to deliver “fluid a drop at a time in response to a little amount of force within a range of forces that can be manually applied to the plunger of the syringe (Column 2, Lines 49-52).”
Modifying the Fischer syringe into the Berndt injection apparatus, results in the plunger (Fischer 14) is withdrawn (Fischer Column 8, Lines 52-58) to draw fluid (one of ordinary skill in the art would conclude withdrawing the plunger would create a pressure differential resulting in a negative pressure which pulls fluid in through Berndt needle tip 41 after Berndt needle 41 is inserted into tissue) from the tissue (Berndt Paragraph 0042) through (in the reverse order as described in Berndt Paragraph 0042, resulting in via 47/67/122/127/137/141) the needle (Berndt 41).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Berndt, in view of Fischer, further in view of Rios (U.S. PGPub 2020/0202747).
As to Claim 14, Berndt, as modified, teaches all the limitations of Claims 1 & 13, but is silent on the type of injection material, so does not explicitly teach the injection material comprises a dermal filler.
Rios describes a similar injection apparatus, and teaches the injection material comprises a dermal filler (Paragraph 0005).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the injection material, as taught by Berndt, as modified, a dermal filler, as taught by Rios, for “treating aesthetic imperfections, restorative cosmetic procedures, procedures for treating migraine, depression, lung aspirations, epidurals, orthopedic procedures, self-administered injections, in vitro procedures, or other therapeutic procedures (Paragraph 0005).”
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Berndt, in view of Manstein (U.S. PGPub 2011/0009737).
As to Claim 15, Berndt teaches all the limitations of Claim 1, but is silent on the wavelength value.
Manstein describes a means of identifying tissues based on reflected light, and teaches the light source has a wavelength between 540 nm and 570 nm (Paragraph 0124).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use a light source wavelength, as taught by Berndt, between 540 nm and 570 nm, as taught by Manstein, to “where optical energy having such wavelengths can be well-absorbed by deoxygenated blood that may be present in veins (Paragraph 0124).”
Berndt, as modified, does not teach the exact claimed range of between 568 nm and 577 nm.
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 light source wavelength to be between 568 nm and 577 nm, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Additionally, Manstein Paragraph 0124 describes the light source wavelength value as a result-effective variable, which affects the ability of specific tissues to absorb light (see MPEP 2144.05(II)(B)).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the light source wavelength to be between 568 nm and 577 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (1955)
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Berndt, in view of Desjardins (Epidural needle with embedded optical fibers for spectroscopic differentiation of tissue: ex vivo feasibility study; 1 June 2011 / Vol. 2, No. 6 / BIOMEDICAL OPTICS EXPRESS 1452 – Applicant provided NPL).
As to Claim 16, Berndt teaches all the limitations of Claim 1, and continues to teach the processor (19), when analyzing the reflected light from the tissue to identify a tissue type, is further configured to:
determine a level of the reflected light from the tissue (Paragraphs 0041/0042), and
identify the tissue type (via comparison with known spectrum standards, as described in Paragraph 0041) associated with the reflected light (Paragraphs 0041/0042) based on determining the level of the reflected light from the tissue (Paragraphs 0041/0042).
Berndt describes comparing the light spectrum to known spectrums, but does not explicitly state the intensity level of the reflected light spectrum is used as the measured and comparison method.
Desjardins describes a means of identifying tissues based on reflected light, and teaches analyzing reflected light intensity and comparing the reflected light intensity to determine a tissue type (Section 3 “Results”, first paragraph, Page 1458).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use reflected light intensity, as taught by Desjardins, as the spectral comparison parameter, as taught by Berndt, to “improve the accuracy of epidural space identification (Abstract).”
As to Claim 17, Berndt, as modified, teaches all the limitations of Claims 1 & 16, and continues to teach the processor (19), when determining an intensity level (Desjardins Section 3 “Results”, first paragraph, Page 1458) of the reflected light from the tissue (Berndt Paragraphs 0041/0042), is further configured to:
compare the intensity level (Desjardins Section 3 “Results”, first paragraph, Page 1458) of the reflected light to a reference value (via comparison with known spectrum standards/reference values, as described in Berndt Paragraph 0041), and
identify the tissue type associated with the reflected light based on comparing the intensity level of the reflected light to the reference value (Desjardins Section 3 “Results”, first paragraph, Page 1458).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matsuo (4,269,192) and Diaz (2018/0333543) describe similar apparatuses as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783