DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of species 3, claims 24-29 in the reply filed on 06/08/2026 is acknowledged.
Claims 1-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
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.
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 24-29 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 24 recites in part: “when the needle drive reciprocates between a drive stroke and a return stroke.” It is unclear how the needle drive can reciprocate between a drive stroke and a return stroke? It is noted that applicant’s disclosure in paragraph 18 stated that “The drive can include an elongate flexible member that reciprocates along a longitudinal axis of the device. The drive can engage with and advance the needle along the needle track when the elongate flexible member is advanced proximally with respect to the housing. The needle can include first and second notches along an inner face of the needle for engaging an antirotate mechanism disposed on at least one of the housing and the deployable needle track”. Clarification is requested.
As to claims 25-29 are also rejected on 112-b due to their dependency from claim 24.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 24-27 is/are rejected under pre-AIA 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Meade et al U.S 5,437,681.
Claim 24: Meade et al disclose a suturing device as best seen in fig. 2 a housing 22 defining an arced needle track therein (it is noted that slidably positioned in a groove or track 32 is a curved stainless steel suturing needle 34, see col. 5, lines 21-23), the arced needle track having a first end and a second end separated by a gap in the housing configured to receive a tissue segment to be sutured, the arced needle track being configured to receive an arced needle therein, the arced needle track being defined at least in part by a radially inner surface and a radially outer surface extending between the first end of the arced needle track and the second end of the arced needle track; a needle drive (it is noted that a drive system as a drive shaft or tubular member 44) configured to drive the arced needle 34 along the arced needle track in a first rotational direction, the needle drive being configured to releasably engage the arced needle and advance the arced needle along the arced needle track in the first rotational direction, and at least one needle brake (pawl 58 is equivalent as a brake- when shaft 44 is rotated in the opposite or counter clockwise direction, there is no engagement of the needle by the pawl 58 so that the needle will not be moved counter clockwise by shaft 44, see col. 6, lines 8-12) extending into the arced needle track from the radially inner surface of the arced needle track. Note that when the instrument is positioned so that the tissues to be sutured are situated at the housing aperture, the needle will penetrate the tissues and span the incision between them. Continued rotation of the needle to return it to its original or home position will pull the thread attached to the blunt or trailing end of the needle down through the tissue on one side of the tissue incision and up through the tissue on the opposite side of the incision. Thus, the suture follows the curved path of the needle to tie the tissues together with a stitch of thread exactly as it would do if a surgeon were suturing manually. Preferably, anchoring means are provided at the trailing end of the suture to prevent the suture from being pulled completely through the tissue (see col. 3, lines 3-22). Alternatively, it would have been obvious that the above description of Meade et al show the at least one needle brake being configured to engage an engagement surface defined in a radially inner surface of the arced needle to prevent the arced needle from rotating in a second rotational direction opposite the first rotational direction when the needle drive reciprocates between a drive stroke and a return stroke. Thus, claim 24 is unpatentable over Meade et al.
Claims 25-27: Meade et al disclose wherein the needle drive 44 is configured to advance the arced needle fully about the arced needle track after executing a plurality of drive strokes. , wherein the at least one needle brake 58 engages in relative sliding contact with a surface of the arced needle as the arced needle is advanced along the first rotational direction. , wherein the at least one needle brake is configured to remain in a fixed relative position with respect to the arced needle track along the first rotational direction as the needle drive reciprocates with respect to the arced needle track 32 (see col. 3, lines 3-22).
Allowable Subject Matter
Claims 28-29 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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