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 with traverse of Group I, Species A, drawn to claims 1-10, in the reply filed on August 8, 2026 is acknowledged. The traversal is on the ground(s) that
First, regarding the election of species requirement, the three claim groupings do not define different species of the manufacturing method. A review of the specification confirms that the application describes one embodiment of the manufacturing method. The specification does describe two embodiments, but those embodiments pertain to the configuration of the rigid component of the manufacturing apparatus, not the manufacturing method. The Official Action does not explain how different claim sets can be said to define different "species" of the manufacturing method when the application itself describes a single embodiment of that manufacturing method.
Section 806.04(e) of the Manual of Patent Examining Procedure makes clear that "[c]laims themselves are never species." The examination guidelines go on to emphasize that "[s]pecies always refer to the different embodiments of the invention." In this application, there is but one disclosed embodiment of the manufacturing method. That the application includes several independent claims defining the manufacturing method with differing degrees of specificity does not change this fact.
The three claim sets here differ from one another in terms of claim scope or claim breadth, but that is not a proper basis for imposing an election requirement. Indeed, Section 806.03 of the Manual of Patent Examining Procedure makes clear that restriction should never be required between claims in an application defining the same essential characteristics of an invention. The reason is "because the claims are not directed to distinct inventions; rather they are different definitions of the same disclosed subject matter, varying in breadth or scope of definition." That is the situation here. That the three sets of claims may define aspects of the manufacturing method using different terminology and may define the manufacturing method varying degrees of specificity does not somehow transform the claim sets into different species.
The election of invention requirement is also traversed because all claims in this application can be examined at the same time without serious burden. The two groups of claims may be capable of different classifications, but the search associated with the elected invention would be expected to extend into search areas required for the non-elected invention. And examining all of the claims of this application at the same time would only involve consideration of one additional claim.
This is not found persuasive because the specification discloses that fusing a first and second member is one aspect (i.e., one embodiment) [0008], that deforming a distal end is another aspect (i.e., another embodiment) [0020], and that generating heat in a distal portion is another aspect (i.e., another embodiment) [0021]. The three Species do NOT differ from one another in terms of claim scope or claim breadth because as argued by Applicant they define aspects of the invention. These aspects are different as disclosed by the specification [0020]-[0021] (i.e., “another aspect”), and thus are distinct. Although there may be some overlap of the search for the two Groups of inventions, there is nothing to indicate that the search for both inventions would be coextensive. The examination on the merits of apparatus claims differs from the examination on the merits of method claims. Therefore, the extra search and/or examination for both inventions poses a serious burden on the examiner making the restriction requirement proper.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and to nonelected Species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 8, 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 6-7 and 10 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 6 recites “the no load state” which lacks antecedent basis. The Examiner suggests the following amendments: “a no load state”.
Claim 10 recites “the no load state” which lacks antecedent basis. The Examiner suggests the following amendments: “a no load state”.
Claims not listed above are rejected as being dependent upon a rejected claim.
Claim Rejections - 35 USC § 102/103
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 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.
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.
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 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Clarke et al. (US 2002/0115963).
Clarke et al. (US 2002/0115963) discloses a manufacturing method for manufacturing a catheter 10 including a catheter body formed by fusing a first member 20 and a second member 39 (figs. 1 and 3-4; [0032], [0037-[0038]), the manufacturing method comprising
irradiating an adjacent portion between the first member 20 and the second member 39 with a laser beam [0032] to fuse the adjacent portion in a close state and in an external force application state, the close state being a state in which an elastically deformable elastic body 40 having laser transmission property (transparent or translucent) and having a hollow portion ([0037] shrink tubing includes a hollow portion as shown in figs. 3-4)) in which the first member 20 and the second member 39 are positioned is in contact with the first member 20 and the second member 39 in the hollow portion due to elastic deformation of the elastic body 40 (figs. 3-4 show the members 20, 39 in the hollow portion of tubing 40; [0037]-[0038] the shrink tubing shrinks (i.e., elastically deforms) to compress members 20, 39), the external force application state being a state in which a component 41 having the laser transmission property (transparent or translucent) applies an external force to the elastic body 40 (i.e., compresses the elastic body 40) to limit a decrease in force due to the elastic deformation for bringing the first member 20 and the second member 39 close to each other (figs. 3-4; [0037-[0038]; tube 41 applies compression force (external force) in addition to that applied by the shrink tubing 40 to bring together the members 20, 39, and such additional compression force limits a decrease in force due to elastic deformation of the shrink tubing).
As to the component 41 having a rigidity greater than the elastic body 40, it would be inherent that the component 41 has a rigidity greater than the elastic body 40 so that tube 41 applies compression force in addition to that applied by the shrink tubing 40 as disclosed by Clarke et al. (US 2002/0115963). As shown in figs. 3-4, shrink tubing 40 compresses the members 20, 39, which shrink tubing is compressed by tube 40. It would be inherent that the component 41 has a rigidity greater than the elastic body 40 so that the tube 41 is able to compress the shrink tubing 40. If Applicant does not agree to such inherency, then the following obviousness reasons apply. Component 41 inherently has a rigidity. It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the rigidity of the component 41 to be greater than the elastic body 40 because such rigidity would have been found in finding operable rigidities for the component 41 in view of the teachings of Clarke et al. (US 2002/0115963) (i.e., that the tube 41 be capable of compressing the tubing 40; in other words, tubes for use as the component 41 must be capable of compressing the tubing 40).
Clarke et al. (US 2002/0115963) further disclose the method:
(Claim 2) wherein at least one of the first member and the second member includes a material that absorbs a laser beam in the adjacent portion ([0032], member 20 is opaque to the laser beam and thus absorbs the laser beam);
(Claim 5) wherein the first member 20 and the second member 39 have a tubular shape (fig. 4), and the component includes a first component 41 that is disposed outside the elastic body 40 in a radial direction intersecting an axial direction of the first member 20 and the second member 39 and applies the external force to the elastic body in the external force application state (fig. 4; [0038]);
(Claim 6) wherein the component 41 includes an insertion portion (tube 41 has a hollow insertion portion as shown in fig. 4) in which the elastic body 40 is positioned, the elastic body 40 being positioned in the insertion portion before the irradiation by virtue of the elastic body 40 being inserted in an inserting direction into the insertion portion (figs. 3-4; [0038] the tube 41 is placed around the tubing 40 in a snug fitting before laser; obvious, if not inherent, for the tubing 40 to be inserted into the tube 41 in an axial insertion direction so that the tube 41 is placed around the tubing), and the elastic body 40 has an outer surface extending in the insertion direction of the elastic body, the outer surface of the elastic body having an interference fit (snug fitting) with the insertion portion of the component in the no load state (before laser causes shrinking) (figs. 3-4; [0037]-[0038]);
(Claim 7) the first member 20 and the second member 39 have a tubular shape (fig. 4), and before the irradiating of the adjacent portion, the elastic body 40 is placed inside the insertion portion of the component 41 with an outer diameter of the elastic body being reduced to be smaller than an inner diameter of the component by virtue of the elastic body being extended in an axial direction of the first member and the second member (figs. 3-4; [0038]; as mentioned above, the tube 41 is placed around the tubing 40 in a snug fitting before laser; as shown in fig. 3-4, it would be obvious to either pull/push the tube 41 over the tubing 40 in a snug fit OR pull/push the tubing 40 into the tube 41 in a snug fit; since the fitting is snug, friction between the tubing 40 and the tube 41 during pull/push will cause the tubing 40 to be extended in an axial direction (i.e., the pull/push direction) because the tubing is elastic, and such axial extension of the tubing 40 during pull/push would also reduce the outer diameter of the tubing 40) (figs. 3-4; [0037]-[0038]).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke et al. (US 2002/0115963) in view of He et al. (US 2008/0135170).
Clarke et al. (US 2002/0115963) discloses the method substantially as claimed, as mentioned above. Clarke et al. (US 2002/0115963) further discloses the method wherein the first member 20 and the second member 39 have a tubular shape (fig. 4), but do not disclose the second member being disposed on a proximal side in an axial direction with respect to the first member.
He et al. (US 2008/0135170) discloses a manufacturing method for manufacturing a catheter wherein components (members) of the catheters are bonded (fused) together by laser [0039], wherein as shown in figs 5 and 6, a long tubular first member has a second member (not labeled) bonded on a proximal side of the first member AND has a third member (not labeled) bonded to a distal side of the first member (see instant specification [0050] for definition of a proximal side and of a distal side).
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify the method of Clarke et al. (US 2002/0115963) wherein the second member is disposed on a proximal side in an axial direction with respect to the first member, as disclosed by He et al. (US 2008/0135170), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
As to claim 4, He et al. (US 2008/0135170) further discloses the method wherein the long tubular first member includes one end and an opposite end, the one end of the first member being positioned adjacent the second member in the axial direction, and the laser beam is also applied to the opposite end of the first member for bonding of the third member to the first member (figs. 5-6; [0039].
It would have been obvious to one of ordinary skill in the art, at the time the invention was made, to further modify the method wherein the first member includes one end and an opposite end, the one end of the first member being positioned adjacent the second member in the axial direction, and the laser beam is also applied to the opposite end of the first member, as disclosed by He et al. (US 2008/0135170), because such a modification is known in the art and would provide an alternative configuration for the method known to be operable in the art.
Allowable Subject Matter
Claims 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not teach or reasonably suggest:
the method, as recited by claim 8, particularly wherein the component includes a plurality of components positioned adjacent one another in a circumferential direction in the external force application state, and the plurality of components applies the external force to the elastic body
toward central axes of the first member and the second member to elastically deform
the elastic body in the external force application state; OR
the method, as recited by claims 9-10, particularly wherein the component includes a second component that is disposed outside the elastic body in the axial direction of the first member and the second member and applies the external force to the elastic body.
Clarke et al. (US 2002/0115963) discloses the component being an elastomeric tube. There is no teaching or suggestion to modify such elastomeric tube to include a plurality of components as disclosed by claim 8 OR to include a first and second component as disclosed by claims 9-10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH S LEYSON whose telephone number is (571)272-5061. The examiner can normally be reached M-F 8am-4:30pm.
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, Sam Xiao Zhao can be reached at 5712705343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.S.L/Examiner, Art Unit 1744
/John J. DeRusso/Primary Examiner, Art Unit 1744
Prosecution Insights