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 .
Response to Arguments
Regarding the 112b indefiniteness to rejections of claim 1, applicant’s amendments, specifically positively reciting hypodermic needle thereby making it clear that the needle is actually required overcomes the previous 112b rejections for claim 1.
Regarding the 112b rejection of claim 6, applicant argues “A person of ordinary skill in the art would understand that this range encompasses shafts that are straight (0 degrees) through shafts that are bent at various angles up to 179 degrees. The inclusion of 0 degrees in the range simply indicates that the shaft may be unbent, which is a clear and definite boundary.” The examiner disagrees, specifically a POSITA would not understand that a limitation that requires a shaft to be bent includes a straight configuration, as well. The examiner highly recommends that applicant to amend the claims to make it clear that both bent (angles from 1 to 179 degrees) and straight (0 degrees) are encompassed. Therefore, this rejection is maintained.
Regarding the 112b of claim 12, applicant argues “the limitation ‘said pulsed laser radiation is controlled wirelessly’ would be understood by a person of ordinary skill in the art to require a wireless control capability for the pulsed laser radiation. This limitation clearly requires some structure or mechanism that enables wireless control, which distinguishes over devices that lack such capability.” The examiner finds this persuasive and the rejection is hereby withdrawn.
Regarding the 103 rejection to Del Giglio, applicant’s amendments and related arguments, specifically regarding “directly embedded in the hypodermic needle body”, are partially moot, based on a new grounds of rejection using a new reference (Lee or Day) and partially unpersuasive. While the examiner agrees that Del Giglio fails to explicitly teach a lens directly embedded in the hypodermic needle body, as the lens is located within the plug/connector/adaptor/coupling (116), and the plug is then located within the socket (112) of the needle body. Therefore, the amendments overcome the previous 102/anticipatory rejection. However, this amounts to a distinction between indirectly embedded versus directly embedded within the needle body, as currently claimed, i.e. the lens embedded in the socket instead of the plug. In the previous office action (prior to the amendment of “directly” was introduced by applicant), the examiner took the position that placing a lens within a coupling/connector/plug versus placing a lens within the socket/body of the device is a mere rearrangement of parts. Regarding this rearrangement of parts, applicant argues that such a modification, specifically directly embedding the lens into the needle body, provides a structural difference and therefore rearrangement of parts is not applicable. The examiner disagrees, as the concept of providing a “structural difference” does not render the use of rearrangement of parts case law improper. Specifically, any/all modifications necessarily result in a structural difference. Therefore, based on applicant’s position, case law can never be used as a rationale to modify/change a device, as the proposed modification results in a structural difference; This is simply not the case. The key is actually whether this modification or structural difference is “critical” or “unexpected”. Applicant’s arguments provide no arguments or evidence as to why this structural difference is critical, unexpected or unobvious. Therefore, the examiner maintains the previous position/use of rearrangement of parts in the 103 rejection in addition to the new grounds/new reference that is necessitated by applicant’s amendments; see new 103 below.
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 6 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.
The limitation “bent at an angle of 0 degrees” is indefinite due to the conflicting nature of “bent” and “0 degrees”. Specifically, a shaft “bent at an angle of 0 degrees” would seemingly not be bent at all, but would be straight. Therefore, it’s unclear if this limitation includes a straight, i.e. unbent, shaft. For examination purposes, the examiner considers a straight, i.e. unbent shaft, at 0 degrees to be encompassed by the current claim language.
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 1, 2, 4-6, 9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,200,332 to Del Giglio in view of US 2012/0172851 to Lee or US 2014/0236023 to Day (provided on 892 mailed 10/30/25).
[Claim 1] An apparatus (Device 100; Figs. 1-2) comprising:
a pulsed laser source for generating pulsed laser radiation (“Device 100 is attached to laser source through optical delivery fiber 118 that is lead into hand piece extension 106” Col 5, lines 6-24. Examples 3-5 in Cols 6-8 disclose a pulse mode of the laser, which is therefore interpreted as a pulsed laser source);
a hypodermic needle (device 100) having a hypodermic needle body (hand piece 110/210 including handpiece extension 106/206) and a shaft (needle 104/204);
an optical fiber (optical delivery fiber 118) for transmitting the pulsed laser radiation from the pulsed laser source to the hypodermic needle body (handpiece 110/210; Col 5, lines 6-24);
a lens (focusing lens stack 114/214) embedded in the hypodermic needle body (106) for focusing said pulsed laser radiation into a shaft of said hypodermic needle (“This variation requires that laser delivery fiber 118 terminates in plug structure 116 that corresponds to socket 112 in hand piece extension 106. When attaching hand piece 110 to laser delivery fiber 118, focusing lens stack 114 is placed into plug 116 before being inserted into socket 112” Col 5, lines 6-24; Fig. 1. The examiner contends that the lens in the plug which is inserted into the handpiece is embedded in the body. In the case that “embedded” is considered a product-by-process limitation, MPEP 2113 states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."); and
an imaging system for guiding said hypodermic needle towards a target site in an organism (“Third, when coupled with x-ray imaging, the present invention may be used to treat various internal body structures for example during surgery. X-ray imaging allows the user to orient the device within the body structures” Abstract. See additional references to “x-ray imaging” throughout the reference);
wherein said pulsed laser radiation light-pipes through said shaft (via optical fiber 102) and is incident on said target site (vascular structure 108; Col 5, lines 6-24; See Fig. 1).
Regarding the limitation “a lens directly embedded in the hypodermic needle body”, Del Giglio fails to explicitly teaches this, as the lens (114) is embedded within an intermediary structure (116) and not directly in the needle. However, whether the lens is located within the plug (116) which is then located within the body (106) or whether the lens is located directly within the body makes no patentable difference, and would be obvious as a matter of design choice, specifically rearrangement of parts; see MPEP 2144.04. To further support this position, either/both Lee or Day teaches this concept. Specifically, in the same field of endeavor, Lee discloses a laser treatment apparatus (Figs. 11-13) that includes a lens (182) directly embedded in the body (cannula 181) to focus light from an input optical fiber (171) to an output optical fiber (172) that emits light to a treatment target (Figs. 11-13 and Pars 0094-98). Similarly, Day teaches a light-emitting needle (Figs. 1a, 1b, 3 and 4) with a focusing lens (18, specifically 18a and/or 18c) embedded directly in the needle body (16, Figs. 1a-b) to focus light (22a) into an optical fiber (22b) within the shaft (12) of the needle (Figs 3-4; at least Par 0064). Therefore, it would have been obvious to modify the needle and lens of Del Giglio such that the lens is embedded directly into the needle body, as taught by Lee or Day, as this is a known configuration/positioning within the art to focus light into an optical fiber located within a needle/cannula shaft. This could also be considered a simple substitution of one known configuration (lens located indirectly in a needle body via an intermediary structure) for another (lens located directly in the needle body) to obtain predictable results (focus light into an optical fiber located within a needle/cannula shaft).
[Claims 2 and 5] The examiner considers the plug (116) and socket (112) to be an adapter that connects the fiber to the body, specifically a friction lock, as a plug and socket by definition operate via friction fit.
[Claim 4] Del Giglio discloses a metal shaft (Col 8, lines 36-43) that is inherently capable of facilitating total internal reflection of light. The examiner contends that “internally polished” is a product by process limitation; see explanation of MPEP 2113 above. It is noted that applicant’s disclosed shaft is also metal, therefore the same structure will inherently function in the same manner. Regardless of whether or not the metal is polished, light will be reflected down the metal shaft. If applicant disagrees, see alternative 103 below.
[Claim 6] Del Giglio discloses a shaft (104/204) that is bent at an angle of 0 degrees; see 112b rejection above.
[Claim 9] MPEP 2115 states “A claim is only limited by positively recited elements. Thus, ‘[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.’”. The examiner contends that the device taught by Del Giglio is capable of irradiate any of the claimed target sites. Specifically, Del Giglio teaches “Essentially, the device and method apply to all body structures that can be affected by laser treatment including superficial, subcutaneous structures, as well as internal organs and tissues” (Col 3, line 59 to Col 4, line 5).
[Claim 11] Any device is disposable, as it is capable of being thrown away. Second, “manufactured as a disposable device” is a product-by-process limitation; see explanation of MPEP 2113 above). Lastly, Del Giglio discloses a disposable device (Col 4, line 33 to Col 5, line 24).
[Claim 12] The laser source taught by Del Giglio is capable of operating in the claimed manner, as it teaches all the necessary structure to be wirelessly controlled; see MPEP 2114. If applicant disagrees, the examiner takes official notice that both wired and wireless control of laser sources is known in the art, and it would be obvious to try/choose either option. If applicant disagrees, see alternative 103 below.
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Del Giglio and Lee or Day as applied to claim 1 above, and further in view of US 2017/0189711 to Shur et al.
[Claim 4] Del Giglio and Lee/Day are discussed above, but fail to explicitly teach a shaft that facilitates total internal reflection. However, in the same field of endeavor, Shur discloses a laser needle device (Figs. 1-2) that includes a shaft including a hollow waveguiding structure (20), specifically a polished aluminum (Pars 0027). Therefore, it would have been obvious to one of ordinary skill in the art to substitute the optical fiber (102) of Del Giglio for a hollow waveguide, e.g. polished aluminum shaft, as this is a simple substitution of one know waveguiding structure for another in a similar laser needle device, as taught by Shur (Pars 0026-27).
[Claim 12] Del Giglio and Lee/Day are discussed above, but fail to explicitly teach a laser source that is controlled wirelessly. However, in the same field of endeavor, Shur discloses a laser needle device that is wirelessly controlled (Pars 0032 and 0053). Therefore, it would have been obvious to one of ordinary skill in the art to modify the laser device taught by Del Giglio to be wireless controlled, as taught by Shur, as this is a known configuration for a similar laser needle device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/ Primary Examiner, Art Unit 3796