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 Group I, Claims 21-34, in the reply filed on June 24, 2026 is acknowledged.
As such Claims 35-40 are withdrawn.
Disposition of Claims
Claims 21-40 are pending.
Claims 21-34 are rejected.
Claims 35-40 are withdrawn.
Claims 1-20 are canceled.
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 limitations are:
"a memory module adapted to collect and record performance information" in Claims 21 & 31.
“a memory module adapted to record identifying information” in Claims 22 & 32.
“physical features [of the outer sheath] configured for tracking, aligning and mating… to manufacturing and/or reprocessing equipment” in Claim 26.
“physical features [of the optical module] for aligning and mating with corresponding physical features on the elongate outer sheath” in Claim 27, as described in Para. [0041] of Applicant’s specification.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(a)
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 21-29 & 31-32 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.
Regarding Claims 21, 23 & 31-32, Claims 21, 23 & 31-32 recite the limitation “a memory module” on Lines 9,1, 3 and 1, respectively, which invokes 35 U.S.C § 112(f) means plus function interpretation as discussed above. While the “memory module” as claimed is mentioned in Paras. [0049] & [0050], Applicant’s specification provides no adequate structure to perform the claimed function of collecting/recording performance information and recording identifying information. Therefore, the examiner concludes that the Applicant’s disclosure does not provide sufficient written description to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Regarding Claim 26, Claim 26 recites the limitation “physical features [of the outer sheath]” on Lines 2-3 which invokes 35 U.S.C § 112(f) means plus function interpretation as discussed above. While the “physical features [of the outer sheath]” as claimed is mentioned in Paras. [0052], Applicant’s specification provides no adequate structure to perform the claimed function of tracking, aligning and mating the elongate outer sheath to manufacturing/reprocessing equipment. Therefore, the examiner concludes that the Applicant’s disclosure does not provide sufficient written description to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Regarding Claims 22, 24-25, 27-29, Claims 22, 24-25, 27-29 are rejected as being dependent upon claims previously rejected under 35 U.S.C. § 112(a).
Claim Rejections - 35 USC § 112(b)
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 21-29 & 31-32 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.
Regarding Claims 21, 23, 26, 31 & 32, claim limitations “a memory module” and “physical features [of the outer sheath]” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure does not provide adequate structure to perform the claimed function of collecting/recording performance information/identifying information and tracking, aligning and mating the elongate outer sheath to manufacturing/reprocessing equipment, respectively. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding Claim 31, Claim 31 recites the limitation “a handle removably mounted at the proximal end of the elongate outer sheath” on Lines 1-2. There is ambiguous antecedent basis of this limitation in the claims as it is unclear whether the “handle” is the same as the “handle” previously recited on Line 11 of Claim 30, or a separate, different handle. For the purpose of examination, “a handle removably mounted at the proximal end of the elongate outer sheath” is being interpreted as “wherein the handle is removably mounted”.
Regarding Claim 32, Claim 32 recites the limitation “components used in the endoscope” on Line 2. There is ambiguous antecedent basis of this limitation in the claims as it is unclear whether the “components” are the same as the “one or more internal subcomponents of the endoscope” previously recited on Lines 6-7 of Claim 30, or separate, different components of the endoscope. For the purpose of examination, “components used in the endoscope” is being interpreted as “the one or more internal subcomponents of the endoscope”.
Regarding Claims 22, 24-25 & 27-29, Claims 22, 24-25 & 27-29 are rejected as being dependent upon claims previously rejected under 35 U.S.C. § 112(b).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 22, Claim 22 only recites elements of the intended use of the performance information of Claim 21 and thus fails to further limit the claimed subject matter of Claim 21.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 21-24, 26-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Langell et al. (hereinafter "Langell") (US 2016/0088999).
Regarding Claim 21, Langell discloses an endoscope (Fig. 2, 110; [0063]) comprising:
an elongate outer sheath (Figs. 2 & 12A, 210/1220; [0071] & [0146]) having a lumen (Fig. 12B, 1270; [0104] & [0150]) extending between a proximal end (see Fig. 5) and a distal end thereof ([0118]), wherein the lumen is adapted for receiving one or more of air, fluids, operative tools, an elongate core, cabling, and/or illumination sources ([0104]);
an optical window (Figs. 6A-6B & 10A-10B, a housing assembly comprising 614/1014 and 635/1035; [0092] & [0121]) mounted at the distal end of the elongate outer sheath ([0118]); and
optical module (Figs. 6A-6B & 10A-10B, an imaging assembly comprising 610/1010, 611/1011, 620/1020, 616 and 640/1040; [0092], [0120] & [0121]) disposed within the distal end of the elongate outer sheath ([0118]), the optical module including an integrated image sensor (Figs. 6A & 10A, 620/1020; [0092] & [0119]) and an optical lens (Figs. 6A & 10A, 611/1011; [0092] & [0121]); and
a handle (Figs. 2 & 12A, 200/1200; [0071] & [0149]) removably mounted at the proximal end of the elongate outer sheath ([0088]) and having an external data connector (Fig. 12A, 1208 for wires; [0138] & [0147]), wherein the handle includes a memory module (Fig. 12A, 1310; [0148]) adapted to collect and record performance information from the endoscope during clinical use ([0151] – [0156]).
The intended use language “the performance information being suitable to inform replacement decisions during reprocessing of the endoscope” does not positively recite any structural limitations so as to carry out the function, accordingly the prior art Langell can carry out the function, i.e. the intended use recited absent any specific structure recited to do so.
Regarding Claim 22, Langell discloses the endoscope of Claim 21. The intended use language “wherein the performance information indicates a need for replacement of under-performing sub-components during reprocessing of the endoscope” does not positively recite any structural limitations so as to carry out the function, accordingly the prior art Langell can carry out the function, i.e. the intended use recited absent any specific structure recited to do so.
Regarding Claim 23, Langell discloses the endoscope of Claim 21. Langell further discloses wherein the memory module is adapted to record identifying information for components used in the endoscope ([0152]).
Regarding Claim 24, Langell discloses the endoscope of Claim 21. Langell further discloses wherein the handle is attached to the elongate outer sheath via a screw thread ([0089]).
Regarding Claim 26, Langell discloses the endoscope of Claim 21. Langell further discloses wherein the elongate outer sheath has external markings (Fig. 5, 540; [0090]) and/or physical features configured for tracking, aligning, and mating the elongate outer sheath to manufacturing and/or reprocessing equipment.
Regarding Claim 27, Langell discloses the endoscope of Claim 21. Langell further discloses wherein the optical module further comprises physical features (Fig. 6A, 616; [0094]) for alignment and mating with corresponding physical features on the elongate outer sheath ([0094]).
Regarding Claim 28, Langell discloses the endoscope of Claim 21. Langell further discloses wherein the optical window and the optical module contain interlocking features (Fig. 6B, 613; [0092] & [0121]).
Regarding Claim 29, Langell discloses the endoscope of Claim 21. Langell further discloses wherein the optical module is press-fit ([0089]) into a receptacle of the optical window (Figs. 10A-10B, 1015; [0121]).
Regarding Claim 30, Langell discloses an endoscope (Fig. 2, 110; [0063]) comprising:
an elongate outer sheath (Figs. 2 & 12A, 210/1220; [0071] & [0146]) having a lumen (Fig. 12B, 1270; [0104] & [0150]) extending between a proximal end (see Fig. 5) and a distal end thereof ([0118]), wherein the lumen is adapted for receiving one or more of air, fluids, operative tools, an elongate core, cabling, and/or illumination sources ([0104]);
an optical window (Figs. 6A-6B & 10A-10B, a housing assembly comprising 614/1014 and 635/1035; [0092] & [0121]) removably mounted at the distal end of the elongate outer sheath ([0118]), the optical window being removable to permit removal of one or more internal subcomponents of the endoscope through the distal end of the elongate outer sheath for testing, harvesting, or replacement thereof (Figs. 6A-6B & 10A-10B, removal of 614/1014 would be capable of permitting removal of one or more internal subcomponents of the endoscope through the distal end of the elongate outer sheath for testing, harvesting, or replacement; [0118]);
an optical module (Figs. 6A-6B & 10A-10B, an imaging assembly comprising 610/1010, 611/1011, 620/1020, 616 and 640/1040; [0092], [0120] & [0121]) disposed within the distal end of the elongate outer sheath ([0118]), the optical module including integrated image sensor (Figs. 6A & 10A, 620/1020; [0092] & [0119]) and an optical lens (Figs. 6A & 10A, 611/1011; [0092] & [0121]); and
a handle (Figs. 2 & 12A, 200/1200; [0071] & [0149]) mounted at the proximal end of the elongate outer sheath ([0088]).
Regarding Claim 31, Langell discloses the endoscope of Claim 30. Langell further discloses a handle removably mounted at the proximal end of the elongate outer sheath ([0088]) and having an external data connector (Fig. 12A, 1208 for wires; [0138] & [0147]), wherein the handle includes a memory module (Fig. 12A, 1310; [0148]) adapted to collect and record performance information from the endoscope during clinical use ([0151] – [0156]).
The intended use language “the performance information being suitable to inform replacement decisions during reprocessing of the endoscope” does not positively recite any structural limitations so as to carry out the function, accordingly the prior art Langell can carry out the function, i.e. the intended use recited absent any specific structure recited to do so.
Regarding Claim 32, Langell discloses the endoscope of Claim 31. Langell further discloses wherein the memory module is adapted to record identifying information for components used in the endoscope ([0152]).
Regarding Claim 33, Langell discloses the endoscope of Claim 30. Langell further discloses wherein the optical window and the optical module contain interlocking features (Fig. 6B, 613; [0092] & [0121]).
Regarding Claim 34, Langell discloses the endoscope of Claim 30. Langell further discloses wherein the optical module is press-fit ([0089]) into a receptacle of the optical window (Figs. 10A-10B, 1015; [0121]).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 25 is rejected under 35 U.S.C. 103 as being unpatentable over Langell et al. (hereinafter "Langell") (US 2016/0088999) in view of Vandre (U.S. 5,919,129).
Regarding Claim 25, Langell discloses the endoscope of Claim 21. Langell fails to explicitly disclose wherein the handle includes a plurality of retractable teeth and the elongate outer sheath includes a plurality of holes, the retractable teeth configured to mate within the holes to couple to the handle to the elongate outer sheath.
However, Vandre teaches an endoscope (Fig. 1, 10; Col. 3, Lines 15-17) comprising:
an elongate outer sheath (Fig. 2, 14; Col. 3, Lines 17-18); and
a handle (Fig. 1, 12; Col. 3, Lines 16-17) removably mounted (Col. 5, Lines 40-47) at the proximal end of the elongate outer sheath (Fig. 1, 14a; Col. 3, Lines 55-57);
wherein the handle includes a plurality of retractable teeth (Fig. 7, 84; Col. 5, Lines 41-43) and the elongate outer sheath includes a plurality of holes (Fig. 7, 85; Col. 5, Lines 43-45), the retractable teeth configured to mate within the holes to couple to the handle to the elongate outer sheath (Col. 5, Lines 40-45).
The advantage of the ball-detent attachment system is to provide both an easier assembly/disassembly and a stress breaker if the endoscope is dropped (Vandre; Col. 5, Lines 45-47).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the elongate outer sheath and handle as disclosed by Langell, to include the ball-detent attachment system taught by Vandre, to provide both an easier assembly/disassembly and a stress breaker if the endoscope is dropped (Vandre; Col. 5, Lines 45-47).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 11,826,023 in view of Langell et al. (hereinafter "Langell") (US 2016/0088999) and Vandre (U.S. 5,919,129).
The claims of ‘023 disclose all the limitations of the instant claims except for wherein the handle includes the memory module; wherein the handle is attached to the elongate outer sheath via a screw thread; wherein the handle includes a plurality of retractable teeth and the elongate outer sheath includes a plurality of holes, the retractable teeth configured to mate within the holes to couple to the handle to the elongate outer sheath; wherein the optical window and the optical module contain interlocking features; and wherein the optical module is press-fit into a receptacle of the optical window.
Regarding Claims 21-34, Langell discloses an endoscope (Fig. 2, 110; [0063]) comprising:
an elongate outer sheath (Figs. 2 & 12A, 210/1220; [0071] & [0146]) having a lumen (Fig. 12B, 1270; [0104] & [0150]) extending between a proximal end (see Fig. 5) and a distal end thereof ([0118]), wherein the lumen is adapted for receiving one or more of air, fluids, operative tools, an elongate core, cabling, and/or illumination sources ([0104]);
an optical window (Figs. 6A-6B & 10A-10B, a housing assembly comprising 614/1014 and 635/1035; [0092] & [0121]) mounted at the distal end of the elongate outer sheath ([0118]); and
optical module (Figs. 6A-6B & 10A-10B, an imaging assembly comprising 610/1010, 611/1011, 620/1020, 616 and 640/1040; [0092], [0120] & [0121]) disposed within the distal end of the elongate outer sheath ([0118]), the optical module including an integrated image sensor (Figs. 6A & 10A, 620/1020; [0092] & [0119]) and an optical lens (Figs. 6A & 10A, 611/1011; [0092] & [0121]); and
a handle (Figs. 2 & 12A, 200/1200; [0071] & [0149]) removably mounted at the proximal end of the elongate outer sheath ([0088]) and having an external data connector (Fig. 12A, 1208 for wires; [0138] & [0147]), wherein the handle includes a memory module (Fig. 12A, 1310; [0148]) adapted to collect and record performance information from the endoscope during clinical use ([0151] – [0156]);
wherein the handle is attached to the elongate outer sheath via a screw thread ([0089]);
wherein the optical window and the optical module contain interlocking features (Fig. 6B, 613; [0092] & [0121]); and
wherein the optical module is press-fit ([0089]) into a receptacle of the optical window (Figs. 10A-10B, 1015; [0121]).
The advantage of the removably memory module disposed in the handle is to attach to new endoscope while persevering the stored data (Langell; [0156]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the memory module as disclosed by '023, to be removable and disposed in the handle as taught by Langell, to attach to new endoscope while persevering the stored data (Langell; [0156]).
Regarding Claims 21-34, Vandre discloses an endoscope (Fig. 1, 10; Col. 3, Lines 15-17) comprising:
an elongate outer sheath (Fig. 2, 14; Col. 3, Lines 17-18); and
a handle (Fig. 1, 12; Col. 3, Lines 16-17) removably mounted (Col. 5, Lines 40-47) at the proximal end of the elongate outer sheath (Fig. 1, 14a; Col. 3, Lines 55-57);
wherein the handle includes a plurality of retractable teeth (Fig. 7, 84; Col. 5, Lines 41-43) and the elongate outer sheath includes a plurality of holes (Fig. 7, 85; Col. 5, Lines 43-45), the retractable teeth configured to mate within the holes to couple to the handle to the elongate outer sheath (Col. 5, Lines 40-45).
The advantage of the ball-detent attachment system is to provide both an easier assembly/disassembly and a stress breaker if the endoscope is dropped (Vandre; Col. 5, Lines 45-47).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the elongate outer sheath and handle as disclosed by ‘023, to include the ball-detent attachment system taught by Vandre, to provide both an easier assembly/disassembly and a stress breaker if the endoscope is dropped (Vandre; Col. 5, Lines 45-47).
Claims 21-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim1-20 of U.S. Patent No. 12,102,288 in view of Langell et al. (hereinafter "Langell") (US 2016/0088999) and Vandre (U.S. 5,919,129).
The claims of ‘288 disclose all the limitations of the instant claims except for wherein the handle is removably mounted and has the external data connector and includes the memory module; wherein the handle is attached to the elongate outer sheath via a screw thread; and wherein the handle includes a plurality of retractable teeth and the elongate outer sheath includes a plurality of holes, the retractable teeth configured to mate within the holes to couple to the handle to the elongate outer sheath.
Regarding Claims 21-34, Langell discloses an endoscope (Fig. 2, 110; [0063]) comprising:
an elongate outer sheath (Figs. 2 & 12A, 210/1220; [0071] & [0146]) having a lumen (Fig. 12B, 1270; [0104] & [0150]) extending between a proximal end (see Fig. 5) and a distal end thereof ([0118]), wherein the lumen is adapted for receiving one or more of air, fluids, operative tools, an elongate core, cabling, and/or illumination sources ([0104]);
an optical window (Figs. 6A-6B & 10A-10B, a housing assembly comprising 614/1014 and 635/1035; [0092] & [0121]) mounted at the distal end of the elongate outer sheath ([0118]); and
optical module (Figs. 6A-6B & 10A-10B, an imaging assembly comprising 610/1010, 611/1011, 620/1020, 616 and 640/1040; [0092], [0120] & [0121]) disposed within the distal end of the elongate outer sheath ([0118]), the optical module including an integrated image sensor (Figs. 6A & 10A, 620/1020; [0092] & [0119]) and an optical lens (Figs. 6A & 10A, 611/1011; [0092] & [0121]); and
a handle (Figs. 2 & 12A, 200/1200; [0071] & [0149]) removably mounted at the proximal end of the elongate outer sheath ([0088]) and having an external data connector (Fig. 12A, 1208 for wires; [0138] & [0147]), wherein the handle includes a memory module (Fig. 12A, 1310; [0148]) adapted to collect and record performance information from the endoscope during clinical use ([0151] – [0156]); and
wherein the handle is attached to the elongate outer sheath via a screw thread ([0089]).
The advantage of the removably memory module disposed in the handle is to attach to new endoscope while persevering the stored data (Langell; [0156]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the memory module as disclosed by ‘288, to be removable and disposed in the handle as taught by Langell, to attach to new endoscope while persevering the stored data (Langell; [0156]).
Regarding Claims 21-34, Vandre discloses an endoscope (Fig. 1, 10; Col. 3, Lines 15-17) comprising:
an elongate outer sheath (Fig. 2, 14; Col. 3, Lines 17-18); and
a handle (Fig. 1, 12; Col. 3, Lines 16-17) removably mounted (Col. 5, Lines 40-47) at the proximal end of the elongate outer sheath (Fig. 1, 14a; Col. 3, Lines 55-57);
wherein the handle includes a plurality of retractable teeth (Fig. 7, 84; Col. 5, Lines 41-43) and the elongate outer sheath includes a plurality of holes (Fig. 7, 85; Col. 5, Lines 43-45), the retractable teeth configured to mate within the holes to couple to the handle to the elongate outer sheath (Col. 5, Lines 40-45).
The advantage of the ball-detent attachment system is to provide both an easier assembly/disassembly and a stress breaker if the endoscope is dropped (Vandre; Col. 5, Lines 45-47).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the elongate outer sheath and handle as disclosed by ‘288, to include the ball-detent attachment system taught by Vandre, to provide both an easier assembly/disassembly and a stress breaker if the endoscope is dropped (Vandre; Col. 5, Lines 45-47).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2019/0357753; US 2018/0263464; US 2017/0135558; US 2014/0142383; US 2011/0193948; US 2009/0124855; US 2009/0076329; US 2005/0277808; U.S. 6,537,207; U.S. 6,086,528 and U.S. 4,222,375.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
