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 Amendment
The amendment filed on or after April 15, 2026 has been entered. Claims 1-21 are pending in the application. Claims 10-20 are withdrawn by applicant’s election without traverse filed on August 11, 2025. In response to the applicant’s arguments and amendments, a more detailed action and references are provided.
Response to Arguments
The arguments filed April 15, 2026 have been fully considered, but they are not fully persuasive. Regarding the applicant’s arguments that:
Applicant’s amendments to claims 2 and 3 overcome the previously set forth 112b rejection: The examiner agrees with the assertion. The previously set forth 112b rejection of claims 2 and 3 is withdrawn.
Regarding the Interview Summary- the applicant’s remarks state that “it was agreed that the present rejection under 25 U.S.C. 103 would be overcome [via the proposed amendment]:” With regard to this assertion, the examiner notes a discrepancy in the record (and in particular with regard to the interview summary record of the previous examiner) which states that “no agreement was reached” with regard to the whether the “proposed amendment would overcome the current rejection given under 35 U.S.C 103.” Unfortunately, the previous examiner is unavailable to address the discrepancy. As such, the current examiner provides independent analysis of the claims, as currently amended with regard to the prior art. The result of this analysis is that a revised rejection is provided in view of Clarke (US 20020115963 A1) which teaches the limitations of the independent claim as amended (see section of office action regarding claim 1) As a result, the arguments made in view of the Watanabe reference are considered moot.
The primary reference cited by the previous examiner does not appear in the PTO-892: The examiner appreciates this observation. With regard to the current office action, an updated version of the PTO-892 is provided with the Watanabe reference included in addition to the references relied upon in this action.
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 -3, 6, 8-9 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clarke US-20020115963-A1):
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Regarding Claim 1: Clarke teaches a system for forming a medical device (system…” for forming a heat weld between a catheter shaft and a surrounding balloon” Abstract), comprising:
a first tubular member (“balloon” Figure 1 Element 30 [0028]) comprising a first polymer (“a balloon formed of thermoplastic polymeric material that is transparent or translucent to red and near-infrared light.” Abstract);
a second tubular member (“Catheter shaft” [0028] Figure 1 Element 20) comprising a second polymer (“catheter shaft formed from polymeric material that is opaque to red and near-infrared light” Abstract),
wherein the first tubular member defines a lumen (“Balloon 30 may be inflated and deflated through a lumen…which includes a “guidewire lumen” Figure 2 Element 25) configured to receive at least a portion of the second tubular member (Figure 1 Element 20) therein to define a joint region (“joints” [0031]);
a compression sleeve (“shrink tubing” [0037] Figure 3 Element 40) configured to receive at least a portion of the first tubular member (“ballon neck shaft” Figure 3 Element 39) at the joint region (“joints” [0031]);
and an energy source (“The preferred source of energy is a laser beam” [0032]) comprising a fiber laser (“Optical fiber 61 brings energy from the laser generator, not shown,” [0041]) being positioned and configured to direct an energy beam to deliver energy to the joint region (“joints” [0031] Configuration/ Positioning shown in Figure 6) to thermally weld the first tubular member (Figure 6 Element 30) to the second tubular member (Figure 6 Element 20),
wherein the energy comprises a wavelength of radiation transmittable through the sleeve and the first tubular member (“To heat the joint area, the laser beam is transmitted radially into the assembly through balloon neck 39 and impinging on shaft 20. Neck 39, and typically entire balloon 30, are formed from a thermoplastic polymer that is transparent or translucent to red and near-infrared energy so that there is little or no absorption of energy as it [initially] passes through the neck.” [0032]) , and absorbable directly from the energy beam by the first tubular member (“heat is conducted to surrounding neck 39 [0032]) and the second tubular member (“In catheter shaft 20, at least the distal section is made from a thermoplastic polymer that is opaque to red and near-infrared energy so that it absorbs the laser beam and is directly heated thereby” [0032]) to form a melt zone (“ as the outer surface of the shaft 20 is heated by the laser beam, heat is conducted to surrounding neck 39 until materials of both member melt and mix” [0032] in the joint region) .
Regarding Claim 2: Clarke further teaches that the first tubular member comprises a medical balloon (“balloon” Figure 1 Element 30 [0028]) …
Regarding Claim 3: Clarke further teaches that the second tubular member comprises a catheter body, a rigid hub, a luer, or an extension tube (as cited in the section regarding Claim 1 “the second tubular member is a “Catheter shaft” [0028] Figure 1 Element 20 which is a catheter body)
Regarding Claim 6: Clarke further teaches that the wavelength of the fiber laser is within a range from about 1500 nm to about 2200 nm (“wavelength of 630-1580nm “[0032]).
Regarding Claim 8: Clarke further teaches that the compression sleeve (“shrink tubing” [0037] Figure 3 Element 40) is configured to compress an inner surface (inner surface of Figure 3 Element 39) of the first tubular member against an outer surface of the second tubular member (Outer surface of Element 20 as shown in Figure 3).
Regarding Claim 9: Clarke further teaches that wherein the compression sleeve (“shrink tubing” [0037] Figure 3 Element 40) comprises a tubular heat-shrinkable sleeve configured to compress the joint region in response to thermal energy (“ Hot air may be applied to shrink tubing 40 so that it applies compression forces to the weld joint, holding balloon neck 39 and shaft 20 together” [0037]).
Regarding Claim 21: Clarke further teaches the system further comprising at least one optical component (“lens” [0041] Figure 6 Element 64) configured to one or both of direct or focus the energy beam to the joint region (configuration shown in Figure 6).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US-20020115963-A1) in view of Drake (US-20160001063-A1):
Regarding Claims 4: Clarke teaches that the compression sleeve (“shrink tubing” [0037] Figure 3 Element 40) comprises a heat- shrinkable sleeve (“Hot air may be applied to shrink tubing 40 so that it applies compression forces to the weld joint, holding balloon neck 39 and shaft 20 together” [0037]).
Clarke does not explicitly teach that the sleeve comprises fluorinated ethylene propylene.
However, Drake does teach a catheter apparatus (Abstract) wherein a sleeve (1-265) is made of a heat shrinkable material that comprises fluorinated ethylene propylene (“According to some methods, sleeve 1-265 is formed of a heat-shrinkable material, such as Fluorinated ethylene propylene (FEP)” [0081]) is used in a fusing step
Therefore, it would be obvious to one of ordinary skill in the art at the time of invention to modify the invention of Clarke such that the material of the sleeve comprised fluorinated ethylene propylene as taught by Drake as Fluorinated ethylene propylene is known for its excellent chemical resistance, high-temperature performance, and high transparency, making it ideal for biomedical devices for the purpose of compression to the first tubular members and providing chemical resistance, high-temperature performance, and high transparency during the fusing process and allow “for more of a length of an instrument/device, such as a medical electrical lead, within catheter 100, to extend into the patient's body and reach a more distal target site” [0052] .
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Clarke (US-20020115963-A1) in view of Mahapatra (US-20040240804-A1):
Regarding Claims 5: Clarke teaches that the system comprises a fiber laser
Clarke does not specify that the fiber laser comprises a thulium fiber laser.
However, Mahapatra teaches a system for (“laser bonding” [0071]) wherein the laser is a thulium fiber laser (“thulium fiber laser” [0071])
Therefore, it would be obvious to one of ordinary skill in the art at the time of invention to modify the invention of Clarke such that the laser used is a thulium fiber laser as taught by Mahapatra as “thulium fiber lasers are CW lasers…typically better than pulsed lasers for polymer bonding since high peak power of pulsed lasers may result in local burning from impurities” [0071])
Regarding Claims 7: Clarke does not teach that the wavelength of the fiber laser is about 1940 nm.
However, Mahapatra teaches a system for (“laser bonding” [0071]) wherein the laser is a thulium fiber laser (“thulium fiber laser” [0071]) w which has a wavelength of about 1940nm (the thulium fiber laser “operates in the wavelength range of 1.8 to 2.0 micro meter range” which equates to 1800 to 2000 nm [0071])
Therefore, it would be obvious to one of ordinary skill in the art at the time of invention to modify the invention of Clarke such that the laser used is a thulium fiber laser with an operating wavelength of about 1940nm as taught by Mahapatra as “thulium fiber lasers are CW lasers…typically better than pulsed lasers for polymer bonding since high peak power of pulsed lasers may result in local burning from impurities” [0071])
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 SOLAN OLIVA whose telephone number is (571-)272-2518. The examiner can normally be reached Monday-Thursday 7:00-3:00.
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, Ibrahime Abraham can be reached at (571) 270-8241. The fax phone number for the organization where this application or proceeding is assigned is 571-270-5569.
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/SOLAN OLIVA/Examiner, Art Unit 3761
/IBRAHIME A ABRAHAM/Supervisory Patent Examiner, Art Unit 3761
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