DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group 2, claims 17-39 in the reply filed on 11/20/2025 is acknowledged. Claims 1-16 are now cancelled by the applicant.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 22-25, 27, 28, 34, 36-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 22, 36 recites in part “at least a portion of the arced needle is defined in part by a tapered leading tip region, an end region, and a first indentation formed into the at least a portion of the arced needle between the tapered leading tip region and the end region, the first indentation being configured to receive a drive element of the drive system of the suturing device.” Further, this limitation is only disclosed in claim 7 of the original disclosure which Pub dated on 2/15/2024 and claim 7 is now cancelled by the applicant on 11/20/2025. Thus, the new claims 22, 36 filed on 11/20/2025, “at least a portion of the arced needle is defined in part by a tapered leading tip region, an end region, and a first indentation formed into the at least a portion of the arced needle between the tapered leading tip region and the end region, the first indentation being configured to receive a drive element of the drive system of the suturing device” adds new matter to the claim.
Claims 23-25 are also rejected under 112(a) because they depend from claim 22.
Claims 37-38 are also rejected under 112(a) because they depend from claim 36.
Claim 27 recites in part “at least a portion of the arced needle is defined at least in part by an arcuately-shaped planar surface that is oriented parallel to the arced needle track of the suturing device.” Further, this limitation is only disclosed in claim 11 of the original disclosure which Pub dated on 2/15/2024 and claim 11 is now cancelled by the applicant on 11/20/2025. Thus, the new claim 27 filed on 11/20/2025, “at least a portion of the arced needle is defined at least in part by an arcuately-shaped planar surface that is oriented parallel to the arced needle track of the suturing device” adds new matter to the claim.
Claim 28 recites in part” at least a portion of the arced needle is less than about 190 degrees in toroidal extent”. It is noted that the term a portion of the arced needle is less than about 190 degrees in toroidal extent which introduces new matter into the claim. Further, the written description in the original disclosure pub dated 2/15/2024 that fails to describe this subject matter. It is noted that paragraph 17, line 6 which discloses “the needle having a first end, a second end, and a generally toroidal body.” Thus, the amendment filed on 11/20/2025 “at least a portion of the arced needle is less than about 190 degrees in toroidal extent in claim 28” adds new matter to the claim.
Claim 34 recites in part “wherein the engagement formed between the housing and the needle delivery device forms an alignment between the housing and the needle delivery device to permit the at least a portion of the arced needle to be transferred from the needle delivery device to the arced needle track of the suturing device”.”. It is noted that the term wherein the engagement formed between the housing and the needle delivery device forms an alignment between the housing and the needle delivery device to permit the at least a portion of the arced needle to be transferred from the needle delivery device to the arced needle track of the suturing device” which introduces new matter into the claim. Further, the written description in the original disclosure pub dated 2/15/2024 that fails to describe this subject matter. It is noted that paragraph 56, lines 6-7 which discloses “a distal stop plate 182b is provided to facilitate axial alignment between loader 180 and suture head 100. ” Thus, the amendment filed on 11/20/2025 “wherein the engagement formed between the housing and the needle delivery device forms an alignment between the housing and the needle delivery device to permit the at least a portion of the arced needle to be transferred from the needle delivery device to the arced needle track of the suturing device in claim 34” adds new matter to the claim.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 17-21, 26, 29-33, 35, 39 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Meade et al U.S 5,437,681 (Cited IDS filed on 10/24/2023).
Claim 17: Meade et al disclose a suturing device system comprising:
a suturing device as best seen in fig. 2, the suturing device comprising a housing 22 defining an arced needle track (it is noted that slidably positioned in the groove or track 32 is a curved medical grade stainless steel suturing needle 34, see col. 5, lines 21-23), the arced needle track being configured to slidably receive an arced needle 34 therein; and a needle delivery device containing at least a portion of an arced needle 34, fig. 2 therein; wherein the needle delivery device is configured to engage with at least a portion of the housing 22 of the suturing device; and wherein following engagement between the needle delivery device and the suturing device (it is noted that pawl 58, figures 2, 6a that attached to a tubular member 44 to drive the needle at the axis), the at least a portion of the arced needle 34 is configured to be at least partially loaded from the needle delivery device into the arced needle track of the housing of the suturing device by advancing a portion of the needle delivery device along a direction that intersects the arced needle track of the suturing device (it is noted that the delivery device is along the direction that intersect the arced needle track when the needle 34 is rotated in it curved track 32 that would have to intersect one of the notch on the face of the needle as best seen in fig. 6b).
Claims 18, 30: Meade et al disclose wherein the needle delivery device defines a cavity therein to contain the at least a portion of the arced needle (it is noted that fig. 5a shows cartridge 14 has a window; figures 6a-I shows a needle 34 protrudes through the window for piercing tissue).
Claims 19, 31: Meade et al disclose wherein the cavity of the needle delivery device at least partially surrounds the at least a portion of the arced needle (it is noted that fig. 5a shows cartridge 14 has a window; figures 6a-I shows a needle 34 protrudes through the window for piercing tissue).
Claims 20,32: Meade et al disclose wherein the cavity of the needle delivery device is defined by a curvature that matches a curvature of the at least a portion of the arced needle (said needle has a circular curvature see Meade et al in claim 17).
Claims 21, 35: Meade et al disclose herein the suturing device further comprises a drive system (for-example, a drive shaft or tubular member 44), wherein the drive system is configured to engage the at least a portion of the arced needle 34 after the at least a portion of the arced needle is loaded from the needle delivery device (fig. 2) into the arced needle track.
Claims 26, 39: Meade et al disclose wherein the at least a portion of the arced needle includes a length of suturing material operably coupled thereto (fig. 6a that has suture that is attached to the needle end 34b that is being stored in pouch 40, see col. 9, lines 61-64).
Claim 29: Meade et al disclose a suturing system comprising: a suturing device as best seen in fig. 2, the suturing device comprising a housing 22 defining an arced needle track (it is noted that slidably positioned in the groove or track 32 is a curved medical grade stainless steel suturing needle 34, see col. 5, lines 21-23), the arced needle track being configured to slidably receive an arced needle 34 therein; and a needle delivery device containing at least a portion of an arced needle 34 therein; wherein the at least a portion of the arced needle is configured to be loaded from the needle delivery device into the arced needle track of the housing of the suturing device by rotationally advancing at least a portion of the needle delivery device along a rotational direction that intersects the arced needle track of the suturing device. It is noted that the delivery device is along the direction that intersect the arced needle track when the needle 34 is rotated in it curved track 32 that would have to intersect one of the notches on the face of the needle as best seen in fig. 6b.
Claim 33: Meade et al disclose wherein the needle delivery device is configured to form an engagement with at least a portion of the housing of the suturing device prior to advancing the portion of the needle delivery device along the direction that intersects the arced needle track of the suturing device (It is noted that the delivery device is along the direction that intersect the arced needle track when the needle 34 is rotated in it curved track 32 that would have to intersect one of the notches on the face of the needle as best seen in fig. 6b).
Conclusion
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/VI X NGUYEN/Primary Examiner, Art Unit 3771