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 1 in the reply filed on 12/29/2025 is acknowledged. Upon review of the newly added claims, a further election is required.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8, 24-27, drawn to a tissue-engaging pad classified in A61B18/1445.
II. Claims 21-23, 28-30, drawn to a method of assembling a tissue-engaging pad to a jaw of a harmonic tissue cutter, classified in A61B17/320092.
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus can be used in a materially different process without a jaw of a harmonic tissue cutter. Instead, the apparatus can be used as a pad for a pair of tissue gripping forceps.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Regardless of which group is elected, a further election of Species is required. This application contains claims directed to the following patentably distinct sub-species:
Sub-species A) a single continuous rail comprising a flange to be snap fitted into the slot of a corresponding jaw (Figs. 2-3)
Sub-species B) a single continuous rail comprising a cap adjacent the distal end to cover the distal end of the slot in the jaw (Fig. 10).
The species are independent or distinct because their distinct structure and mechanism for coupling to the jaw of the harmonic tissue cutter. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: The species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Christopher Gloria (Applicant’s representative) on 2/25/2026 a provisional election was made without specifying traverse to prosecute the invention of Group I, Sub-species A (Figs. 2, 3), claims 1-8. Affirmation of this election must be made by applicant in replying to this Office action. Claims 21-30 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to because of the gray shading used to indicate the inventive features in Figs. 1B, 1C, 1D, 3A, 3B, 4A, 4B, 5A, 5B, 6A, 8A, 8B, 9A, 9C, 10A, 10C, 11, 12A, 12B, 13A, 13B, 14, 15A, 15B. The drawings must be of sufficient quality such that all details in the drawings are reproducible in black and white in a printed patent (MPEP 608.02 and 37 CFR 1.84). The gray shading renders the images unclear and may affect the quality of images if and when the images are reproduced for printing in a patent.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Messerly (US 6432118).
Messerly discloses the following limitations:
Claim 1. A tissue-engaging pad (208) (Figs. 26-33) for a harmonic tissue cutter (10) (Fig. 1; col. 4, ll. 54 – col. 5, ll. 8) that comprises a shaft (174) and a jaw (202) pinned to the shaft (col. 10, ll. 1-12, 42-50), the tissue-engaging pad comprising:
a main body (see annotated figure below) comprising a tissue-engaging surface (210) (col. 10, ll. 27-41); and
a rail (212) configured for insertion into a slot (226) of the jaw to retain the tissue-engaging pad to the jaw (col. 11, ll. 7-17), the rail comprising a stem (see annotated figure below) extending from the main body opposite the tissue-engaging surface (the stem extends from top surface 218, while the tissue-engaging surface extends from the opposite bottom surface 219) and a flange (see annotated figure below) supported by the stem, wherein the flange is configured so that the rail is capable of being pressed into the slot in a direction transverse to a longitudinal direction of the slot of the jaw (col. 10, ll. 14-22; the entire tissue pad 208, including the flange, is made of a compliant material and therefore capable of deforming or compressing to fit into the slot in a direction transverse to a longitudinal direction of the slot of the jaw. Further, claim 1 is directed to only the tissue pad and not the harmonic tissue cutter. Therefore, the tissue-engaging pad of Messerly may also be used with any other sized slot in a jaw of another harmonic tissue cutter to allow for the flange to be pressed into the slot as claimed).
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Claim 2. The tissue-engaging pad of claim 1, wherein the flange comprises chamfered corners (see the left and right side of flanges in Fig. 29).
Claim 3. The tissue-engaging pad of claim 1, wherein the rail (212) extends to at least one end face (proximal end face) of the tissue-engaging pad (Figs. 27-28).
Claim 4. The tissue-engaging pad of claim 1, wherein an end (distal end at front end 209) of the rail is spaced from a corresponding end (distal end) of the tissue-engaging pad (Figs. 27-28).
Claim 5. The tissue-engaging pad of claim 4, wherein the end (front face 209) of the rail is chamfered (col. 10, ll. 34-41; col. 11, ll. 7-17).
Claim 6. The tissue-engaging pad of claim 1, wherein the rail (212) is a single continuous rail (Figs. 27-28).
Claim 7. The tissue-engaging pad of claim 1, wherein the main body and the rail are made of the same material (col. 10, ll. 13-26).
Claim 8. The tissue-engaging pad of claim 1, wherein the main body and the rail are formed as a single piece (cross sectional views in Figs. 32-33 illustrate the single piece forming the main body and the rail).
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Faller et al (US 2015/0164532) discloses a rail comprising a stem and flange, wherein the flange is configured so that the rail can be pressed into the slot of a jaw in a direction transverse to a longitudinal direction of the slot of the jaw (Figs. 3A-3C; [0093]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771