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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/18/2025 has been entered.
Response to Amendment
The amendment filed 10/17/2025 has been entered. Claims 1-4 and 6-21 remain pending in the application, and claim 5 is canceled. Applicant’s amendments to the claims have overcome the claim objection and the interpretation of the prior art rejection with respect to Shelton as a primary reference previously set forth in the Final Office Action mailed 08/20/2025, however another rejection in view of Beane et al. is applied as outlined below.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “lubricant application member” in claims 16 and 19; “lubricant discharge member” in claim 8; “excess lubricant removal member” in claims 12 and 18; and “jaw cleaning member” in claims 14 and 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 7-8, 11-12, 14-15, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beane et al. (US PGPub 2002/0022762), hereinafter known as “Beane.”
With regards to claim 1, Beane discloses (Figures 4A-4C) an apparatus 310 configured for use with an end effector 12 of a surgical instrument 10 (paragraphs 46 and 73; figure 4B), comprising:
(a) a housing 310, wherein the housing 310 includes a first housing portion 311 defining a first gap (U-shaped gap as seen in figure 4B), wherein the first gap is configured to receive a jaw of the end effector 12 (functional limitation – paragraph 74 – scope 10 is pressed into the gap and therefore the gap is capable of receiving a jaw since the gap receives a shaft 12 of the scope 10); and
(b) a lubricant application sponge 316 (paragraphs 73-74) fixedly positioned within the first gap, wherein the lubricant application sponge 316 is configured to be loaded with a lubricant for applying the lubricant to a tissue clamping surface of the jaw when the jaw is received within the first gap (functional limitation – paragraphs 73-74– sponge 316 is loaded with fluid from the fluid reservoir 318, can be applicable to a tissue clamping surface of the jaw since the jaw is functionally recited), wherein the lubricant application sponge 316 is configured to absorb the lubricant such that the lubricant application sponge 316 is configured to be saturated with the lubricant (paragraphs 73-74), wherein the lubricant application sponge 316 is configured to remain fixedly positioned within the first gap after applying the lubricant to the tissue clamping surface of the jaw and after removal of the jaw from the first gap (figures 4A-4C; paragraphs 73-74 – functional limitation – sponge 316 is retained within the first housing portion 311 and remains fixedly positioned within during application of the lubricant and removal of the jaw).
With regards to claim 2, Beane discloses wherein the first housing portion 311 defines a U shape to present the first gap (figure 4B – first gap is the space where sponge 316 lies; gap is U-shaped).
With regards to claim 3, Beane discloses wherein the lubricant application sponge 316 includes at least one ridge (figure 4A – see elevated structure of bore 322 of the sponge 316) configured to contact at least one side surface of the jaw 12 when the jaw 12 is received within the first gap for applying the lubricant to the at least one side surface of the jaw 12 (functional limitation – figures 4A-4B; paragraphs 73-74 – “Sponge 316 has a generally cylindrical shape, defining a bore 322 for receiving distal portion 16 of laparoscope 10… Pressing distal portion 16 of scope 10 against sponge 316 draws fluid from reservoir 318 to sponge 316”).
With regards to claim 4, Beane discloses wherein the housing 310 is rigid (figure 4B-4C – housing is structurally solid).
With regards to claim 7, Beane discloses wherein the lubricant application sponge 316 includes a pair of opposed lubricant application surfaces (figure 4A – left and right surfaces of the sponge 316 are interpreted as the opposed lubricant application surfaces), wherein each of the pair of opposed lubricant application surface is exposed within the first gap (figures 4A-4B).
With regards to claim 8, Beane discloses further comprising a lubricant discharge member 324 (see Note below), wherein the lubricant discharge member 324 is configured to selectively direct the lubricant from a lubricant reservoir 318 to the lubricant application sponge 316 (paragraphs 73-74).
Note – 112(f) interpretation – Applicant’s lubricant discharge material is a button, pump bulb, or paddle used to dispense lubricant to the lubricant application member [spec. 000162 and claim 9]; Beane’s lubricant discharge member is a port that allows fluid to enter into the sponge (paragraph 74); therefore both lubricant discharge members are equivalent in dispensing lubricant into the lubricant application sponge.
With regards to claim 11, Beane discloses wherein the housing 310 further includes a second housing portion 312 defining a second gap (see second gap in figure 4B where shaft 12 rests), wherein the second gap is configured to receive the jaw of the end effector 12 (figure 4B; paragraph 75).
With regards to claim 12, Beane discloses further comprising an excess lubricant removal member 332a/332b/332c (see Note below) positioned within the second gap (paragraph 75; figure 4B), wherein the excess lubricant removal member 332a/332b/332c is configured to remove excess lubricant from the tissue clamping surface of the jaw when the jaw is received within the second gap (paragraph 75).
Note – 112(f) interpretation – Applicant’s excess lubricant removal member is a cloth configured to remove excess lubricant from jaws [spec. 000107 and 000112; figure 6]; Beane’s excess lubricant removal member are wipers with grooves used to wipe fluid and tissue from the shaft 12 (paragraph 75); therefore both excess lubricant removal members are equivalent in removing lubricant/fluid.
With regards to claim 14, Beane discloses further comprising a jaw cleaning member 332a/332b/332c (see Note below) positioned within the second gap (paragraph 75; figure 4B), wherein the jaw cleaning member 332a/332b/332c is configured to remove debris from the tissue clamping surface of the jaw when the jaw is received within the second gap (paragraph 75).
Note – 112(f) interpretation – Applicant’s jaw cleaning member is an abrasive, brush, or gauze strip that washes and scrubs debris from the end effector [spec. 000148 and claim 15]; Beane’s jaw cleaning member are wipers with grooves used to wipe fluid and tissue from the shaft 12 (paragraph 75); therefore both jaw cleaning members are equivalent in removing lubricant/fluid.
With regards to claim 15, Beane discloses wherein the jaw cleaning member 332a/332b/332c includes at least an abrasive 330 (paragraph 75 – groove is interpreted as an abrasive as it removes/wipes the fluid from the shaft 12).
With regards to claim 19, Beane discloses (Figures 4A-4C) an apparatus 310 configured for use with an end effector 12 of a surgical instrument 10 (paragraphs 46 and 73; figure 4B), comprising:
(a) a rigid support member 310 (figures 4A-4C); and
(b) a lubricant application member 316 (see Note below; paragraphs 73-74) fixedly secured against movement relative to the rigid support member 310 (sponge 316 is retained within the housing portion 310 and remains fixedly positioned within during application of the lubricant and removal of the jaw), wherein the lubricant application member 316 is configured to confront a jaw of the end effector 12, wherein the lubricant application sponge 316 is configured to be loaded with a lubricant for applying the lubricant to a tissue clamping surface of the jaw when the jaw is confronted by the lubricant application member 316 (functional limitation – paragraphs 73-74– sponge 316 is loaded with fluid from the fluid reservoir 318, can be applicable to a tissue clamping surface of the jaw since the jaw is functionally recited), wherein the lubricant application member 316 is configured to absorb the lubricant such that the lubricant application member 316 is configured to be saturated with the lubricant (paragraphs 73-74).
Note – 112(f) interpretation – Applicant’s lubricant application member is a sponge that applies lubricant to the end effector [spec. 00014 and 00108; figure 6]; Beane’s lubricant application member is a sponge that is capable of being loaded with a lubricant for applying to the end effector (paragraphs 73-74); therefore both lubricant application members are equivalent in applying lubricant to the end effector.
Claim Rejections - 35 USC § 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 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 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Beane in view of Shelton, IV et al. (US PGPub 2018/0235616), hereinafter known as “Shelton.”
With regards to claims 6 and 10, Beane discloses the apparatus as claimed in claim 1. Beane further discloses a heating pad 320 and a heat-conducting tube 314 (paragraph 74). Beane is silent wherein the sponge includes a polymeric foam (claim 6); and an ultraviolet light (UV) emitting device secured to the housing (claim 10).
However, in a similar field of endeavor of lubricant applicators, Shelton teaches wherein the sponge includes a polymeric foam (paragraphs 59-60– “an adjunct can be fabricated is from animal derived collagen, such as porcine tendon, that can then be processed and lyophilized into a foam structure. Gelatin can also be used and processed into a foam”); and
an ultraviolet light (UV) emitting device secured to the housing 305 (figure 10; paragraphs 133-134 – UV element).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Beane to include wherein the sponge includes a polymeric foam as taught by Shelton for the purpose of being selected in accordance with a desired therapy to be delivered to tissue so as to facilitate tissue in-growth (paragraph 65 of Shelton).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the heating pad of Beane for the ultraviolet light (UV) emitting device as taught by Shelton. The difference between the prior art and the claimed invention is that Beane does not teach a UV emitting device. Shelton teaches a similar device comprising a UV emitting device. Accordingly, the prior art references teach that it is known that the heating pad of Beane and the UV emitting device of Shelton are elements that are functional equivalents for providing heat. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the UV emitting device taught by Shelton for the heating elements of Beane because both elements were known equivalents for providing and would have resulted in the predictable results of providing heat to the device.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Beane in view of Tran (US Patent 8,002,486)
With regards to claim 9, Beane discloses the apparatus as claimed in claim 8. Beane is silent wherein the lubricant discharge member includes at least one of a button, a pump bulb, or a paddle.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to deliver a lubricant to the lubricant applicant member, Tran teaches (Figures 1-4) wherein the lubricant discharge member 50 includes at least one of a button 50 (Col 2 lines 45-65).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Beane to include wherein the lubricant discharge member includes at least one of a button as taught by Tran for the purpose of selectively delivering the lubricant to the lubricant application member as needed during live time during the procedure.
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Beane in view of Vendely et al. (US PGPub 2017/0055981), hereinafter known as “Vendely.”
With regards to claim 13, Beane discloses the apparatus as claimed in claim 12. Beane is silent wherein the excess lubricant removal member includes a cloth.
However, in a similar field of endeavor of lubricant applicators, Vendely teaches (Figures 1 and 37) wherein the excess lubricant removal member 2042 includes a cloth (paragraphs 349-350 – “Panel (2042) includes a hydrophilic drying material disposed thereon” – hydrophilic drying material is interpreted as a cloth).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Beane to include wherein the excess lubricant removal member includes a cloth for the purpose of further enhancing the removal of excess lubricant.
Claims 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Beane in view of Batchelor et al. (US PGPub 2019/0262092), hereinafter known as “Batchelor.”
With regards to claim 16, Beane discloses (Figures 4A-4C ) an apparatus 310 configured for use with an end effector 12 of a surgical instrument 10 (paragraphs 46 and 74; figure 4B), comprising:
a housing 310 defining a first gap (U-shaped gap as seen in figure 4B), wherein the first gap is configured to receive a jaw of the end effector 12 (functional limitation – paragraph 74 – scope 10 is pressed into the gap and therefore the gap is capable of receiving a jaw since the gap receives a shaft 12 of the scope 10); and
(b) a lubricant application member 316 permanently positioned within the first gap (figures 4A-4B),
(c) a lubricant (paragraphs 73-74– fluid) carried by the lubricant application member 316 (paragraphs 74-75).
Note – 112(f) interpretation – Applicant’s lubricant application member is a sponge that applies lubricant to the end effector [spec. 00014 and 00108; figure 6]; Beane’s lubricant application member is a sponge that is capable of being loaded with a lubricant for applying to the end effector (paragraphs 73-74); therefore both lubricant application members are equivalent in applying lubricant to the end effector.
Beane is silent wherein the lubricant is configured to inhibit tissue from sticking to the jaw of the end effector when the lubricant contacts the tissue during welding of the tissue via the end effector (claim 16); and wherein the lubricant includes an anti-stick phospholipid solution (claim 21).
However, in a similar field of endeavor of lubricant applicators, Batchelor teaches in paragraph 44 that “The one or more fluids may function to assist a surgeon in performing a procedure, to minimize trauma to a patient, to deliver a drug, deliver a therapy fluid, deliver a lubricant, or a combination thereof... The one or more fluids may prevent tissue from sticking to a blade, an electrode, a jaw, or a combination thereof when the blade, the jaw, or both are used mechanically, electrically, or both... Preferably, the one or more fluids may be lubricant. One example of a preferred fluid is Electro Lube created by Mectra Labs of Bloomfield, Ind. The lubricant may an anti-stick solution… The lubricant may be a lecithin based phospholipid mixture derived from soybean oil. The lubricant may prevent tissue from sticking to the forceps, jaws, blade, or a combination thereof during application of power, electro surgery, or both.”
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lubricant of Beane to include wherein the lubricant is configured to inhibit tissue from sticking to the jaw of the end effector when the lubricant contacts the tissue during welding of the tissue via the end effector; and wherein the lubricant includes an anti-stick phospholipid solution as taught by Batchelor for the purpose of assisting a surgeon in performing a procedure and minimizing trauma to a patient (paragraph 44 of Batchelor).
With regards to claim 17, Beane further discloses wherein the housing 310 defines a second gap opposite the first gap (see second gap in figure 4B where shaft 12 rests), wherein the second gap is configured to receive the jaw of the end effector 12 (paragraph 75).
With regards to claim 18, Beane further discloses further comprising an excess lubricant removal member 332a/332b/332c (see Note below) positioned within the second gap (paragraph 75; figure 4B).
Note – 112(f) interpretation – Applicant’s excess lubricant removal member is a cloth configured to remove excess lubricant from jaws [spec. 000107 and 000112; figure 6]; Beane’s excess lubricant removal member are wipers with grooves used to wipe fluid and tissue from the shaft 12 (paragraph 75); therefore both excess lubricant removal members are equivalent in removing lubricant/fluid.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Beane in view of Hulliger (US PGPub 2012/0181200).
With regards to claim 20, Beane discloses the apparatus as claimed in claim 19. Beane is silent to a multi-pack comprising a plurality of the apparatuses of claim 19, wherein each apparatus of the plurality of apparatuses is releasably coupled relative to the remaining apparatuses of the plurality of apparatuses.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to provide a multi pack of apparatuses, Hulliger teaches (Figures 1-3) a multi-pack 1 comprising a plurality of apparatuses 2, wherein each apparatus 2 of the plurality of apparatuses 1 is releasably coupled relative to the remaining apparatuses of the plurality of apparatuses 1 (paragraphs 8 and 31).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Beane to include a multi-pack, wherein each apparatus of the plurality of apparatuses is releasably coupled relative to the remaining apparatuses of the plurality of apparatuses as taught by Hulliger for the purpose of easily determining how many packings remain which facilitates the determination of when to order a new multi packaging system (paragraph 12 of Hulliger).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 12/09/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771