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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13 and 20, drawn to a modular grip piece for an endoscope handle, a base support radially further out than a palm support, classified in A61B1/00105.
II. Claims 14-19, a modular grip piece for an endoscope handle having two configurations and a base support at a distalmost end, classified in A61B1/00066.
The inventions are distinct, each from the other because of the following reasons:
Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because invention I does not require the base support portion projecting radially outward further than the palm support. The subcombination has separate utility such as a grip piece that does not require the flexible material, classified in A61B1/00066.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all these 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 at least the following reason(s) apply:
(a) the inventions require a different field of search due to their mutually exclusive characteristics (for example, searching different classes/subclasses or electronic resources, or employing different search queries) and the prior art applicable to one species would not likely be applicable to another invention.
(b) 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 a 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(a) of the other invention.
The application comprises claims directed to the following patentably distinct species:
Species A: The device as discussed with reference to Figs.3-10.
Species B: The device as discussed with reference to Figs. 11-12.
These species are independent or distinct because they have mutually exclusive characteristics, thus having a search and/or examination burden by requiring different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries) and the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Further, the prior art applicable to one species would not likely be applicable to another species. 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 held to be generic. Further, applicants are required to point out which claims correspond with which species, including new or amended claims.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species require a different field of search due to their mutually exclusive characteristics (for example, searching different classes/subclasses or electronic resources, or employing different search queries)
(b) the species 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 inventions (ii) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143). and (iii) 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(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 Ethan Goldschen on 24 June, 2026, a provisional election was made without traverse to prosecute the invention of Invention I, Species B, claims 1-13 and 20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-19 are 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 cancellation 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).
Claim Rejections - 35 USC § 112
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
Claims 9-10 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 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.
In regards to claim 9, the claim reads “The body of claim 1, wherein the finger support portion is configured to be positioned adjacent to at least one button of the handle of the medical device when the body is coupled to the medical device, and is configured to fill a space between an index finger and the handle of the medical device.”
As the medical device and finger are unclaimed and could be respectively configured and positioned as desired, claim 9 does not narrow the scope of the claims from claim 1 from which it depends.
In regards to claim 10, the claim reads “The body of claim 1, wherein the finger support portion is configured to be positioned proximate to, and distal, to an end portion of an umbilicus of the medical device when the body is coupled to the handle of the medical device.”
As the medical device is unclaimed, it may be configured and positioned as desired. As such, claim 10 does not narrow the scope of the claims from claim 1 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-13 and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-12 of U.S. Patent No. 12,262,867 (henceforth ‘867). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Present claim 1 Claim 1 of ‘867 unless noted
A body configured to be removably coupled to a handle of a medical device, the body comprising:
a body configured to be removably coupled to a handle of the medical device, wherein the body comprises:
a recess configured to receive the handle of the medical device, wherein the recess extends from a proximal end of the body to a distal end of the body;
a recess configured to receive the handle of the medical device, wherein the recess extends from a proximal end of the body to a distal end of the body;
a palm support portion; a finger support portion proximal to the palm support portion; and a base support portion distal to the palm support portion,
a palm support portion; a finger support portion proximal to the palm support portion; a base support portion distal to the palm support portion;
wherein the base support portion projects radially outward from a central longitudinal axis of the body relative to the palm support portion.
wherein the base support portion projects radially outward from the central longitudinal axis of the body relative to the palm support portion
Present claim 20 Claim 1 of ‘867 unless noted
A body configured to be removably coupled to a handle of a medical device, the body comprising:
a body configured to be removably coupled to a handle of the medical device, wherein the body comprises:
a recess configured to receive the handle of the medical device, wherein the recess extends from a proximal end of the body to a distal end of the body;
a recess configured to receive the handle of the medical device, wherein the recess extends from a proximal end of the body to a distal end of the body;
a palm support portion;
a palm support portion;
a finger support portion proximal to the palm support portion, wherein the finger support portion is configured to couple to the handle at a position on an opposite side of the handle from a first control knob of the handle and a second control knob of the handle;
a finger support portion proximal to the palm support portion;
(the handle and portions thereof are unclaimed and could be configured and arranged in this fashion)
a base support portion distal to the palm support portion, wherein the base support portion projects radially outward from a central longitudinal axis of the body relative to the palm support portion.
a base support portion distal to the palm support portion; wherein the base support portion projects radially outward from the central longitudinal axis of the body relative to the palm support portion
Claim 2 is anticipated by claim 1 of ‘867
Claim 3 is anticipated by claim 1 of ‘867
Claim 4 is identical to claim 3 of ‘867
Claim 5 is anticipated by claim 4 of ‘867
Claim 6 is identical to claim 5 of ‘867
Claim 7 is identical to claim 6 of ‘867
Claim 8 is identical to claim 7 of ‘867
Claim 9 is identical to claim 8 of ‘867
Claim 10 is identical to claim 9 of ‘867
Claim 11 is identical to claim 10 of ‘867
Claim 12 is identical to claim 11 of ‘867
Claim 13 is identical to claim 12 of ‘867
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.
Claims 1, 3-4, 6-11, 13 and 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Papouras et. al. (USPN 8,092,373).
In regards to Claim 1, Papouras discloses a body [Fig.2] configured to removably couple to a handle of the medical device [100, Figs.1, 10, abstract, col.4 ll.20-22], wherein the body comprises:
a recess [space between protrusions 38, the space labeled as 40 in Fig.7, Figs.2-3, 7] configured to receive the handle of the medical device [Fig.10], wherein the recess extends from a proximal end of the body to a distal end of the body;
a palm support portion [portion of 30 about apex 34, including side-portions extending “downward” therefrom to 20 on either side, Figs.6, 10];
a finger support portion [topside 32 to the left of the portion about apex 34 in Fig.6, Figs.6, 10] proximal to the palm support portion; and
a base support portion [the portion of outermost of the protruding rings at 12 which is to the right of 34, Fig.6, and areas of 30 adjacent thereto and distal to the palm support portion, Figs.6] distal to the palm support portion, wherein the base support portion extends radially outward, relative to the palm support portion [Fig.6: note that the applicant has not set forth what this is radially outward relative to- here any arbitrary axis through a reasonably designated “center” of the hand assist device could be chosen, or any reasonably designated “center”],
In regards to claim 3, Papouras discloses the hand assist device of claim 1, wherein a radially-inner surface of the body [inner surface about channel 40 in Figs.7-8, col.4 ll.8-10] extends more than 180 degrees around a central longitudinal axis of the body [Fig.8; this central longitudinal axis could be placed in several places here, however if placed about where the line from 40 reaches the surface of the object, the inner surface extends more than 180 degrees about this axis],
In regards to claim 4, Papouras discloses the hand assist device of claim 1, wherein the finger support portion is disposed at the proximal end of the body [Fig.6] and extends less than 180 degrees around the central longitudinal axis of the body [the finger support portion could be arbitrarily designated in this fashion].
In regards to claim 6, Papouras discloses the device of claim 1, wherein the body defines a longitudinal opening [opening between the distal portions of 38, Figs.2, 7] between two longitudinal edges of the body, the longitudinal opening leading to the recess [Fig.2; this leads to the space between the portions 38, labeled as 40 in Fig.7].
In regards to claim 7, Papouras discloses the device of claim 1, wherein the palm support portion is configured to fill a space between a palm and a handle body of the endoscope handle and includes a curved portion that protrudes radially outward from the central longitudinal axis of the body [Fig.10].
In regards to claim 8, Papouras discloses the hand assist device of claim 27, wherein the curved portion has an apex at a radially-outermost portion of the body [34, Figs.6, 10].
In regards to claim 9, Papouras discloses the hand assist device of claim 21, wherein the finger support portion is configured to be positioned adjacent to at least one button of the handle of the medical device when the hand assist device is coupled to the medical device, and is configured to fill a space between an index finger and the handle of the medical device [Fig.10, the endoscope could be held in this fashion, and an appropriate endoscope could be used with the hand assist device. Also see the related 112 (d) rejection of claim 9 hereinabove.].
In regards to claim 10, Papouras discloses the hand assist device of claim 21, wherein the finger support portion is configured to be positioned proximate to, and distal, to an end portion of an umbilicus of the medical device when the hand assist device is coupled to the handle of the medical device [Fig. 10: Given the appropriate, functionally-claimed endoscope. Also see the related 112 (d) rejection of claim 10 hereinabove.].
In regards to claim 11, Papouras discloses the hand assist device of claim 21, wherein the base support portion is positioned at a distalmost end of the body [Fig.6].
In regards to claim 13, Papouras discloses the hand assist device of claim 21, wherein the body includes a flexible material such that the recess can be forced between an at-rest configuration and an enlarged configuration for receiving the medical device [col.4 ll.20-23; further as all materials possess the property of elasticity, the device can be reversibly deformed to at least some extent.].
In regards to Claim 20, Papouras discloses a body [Fig.2] configured to removably couple to a handle of the medical device [100, Figs.1, 10, abstract, col.4 ll.20-22], wherein the body comprises:
a recess [space between protrusions 38, the space labeled as 40 in Fig.7, Figs.2-3, 7] configured to receive the handle of the medical device [Fig.10], wherein the recess extends from a proximal end of the body to a distal end of the body;
a palm support portion [portion of 30 about apex 34, including side-portions extending “downward” therefrom to 20 on either side, Figs.6, 10];
a finger support portion [topside 32 to the left of the portion about apex 34 in Fig.6, Figs.6, 10] proximal to the palm support portion, wherein the finger support portion is configured to couple to the handle at a position on an opposite side of the handle from a first control knob of the handle and a second control knob of the handle [Fig.10: the handle and portions thereof are unclaimed and could be configured and arranged in this fashion]; and
a base support portion [the portion of outermost of the protruding rings at 12 which is to the right of 34, Fig.6, and areas of 30 adjacent thereto and distal to the palm support portion, Figs.6] distal to the palm support portion, wherein the base support portion extends radially outward, relative to the palm support portion [Fig.6: note that the applicant has not set forth what this is radially outward relative to- here any arbitrary axis through a reasonably designated “center” of the hand assist device could be chosen, or any reasonably designated “center”],
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
Claim 12 is rejected under 35 U.S.C. 103(a) as being unpatentable over Papouras et. al. (USPN 8,092,373) in view of Good et al. (USPN 5,353,474).
In regards to claim 12, Papouras discloses the device of claim 1, however does not positively disclose wherein the body further comprises a surface protrusion configured to be positioned between a middle finger and a ring finger of a user, and wherein the surface protrusion is positioned between the palm support portion and the finger support portion.
Papouras further discloses wherein the finger support portion is above the palm support portion when the device is coupled to the endoscope [Fig.10].
Good teaches a body [20, Figs.2-4, col.4 ll.32-36] configured to removably couple to a handle [16, Figs.1-3, col.4 ll.30-36], wherein the body has a palm support portion [surface in the box indicated by the lower arrow in Fig.10 provided hereinbelow for illustrative purposes, Figs.3, 10] and a finger support portion [surface in the box indicated by the upper arrow in Fig.10 provided hereinbelow for illustrative purposes, col.7 ll.4-8] above the palm support portion when the body is coupled to the handle, and
wherein the body further comprises a surface protrusion [second to top ridge of 33, Fig.8] configured to be positioned between a middle finger and a ring finger, the surface protrusion being positioned between the palm support portion and the finger support portion [Figs.8-10].
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Good teaches that the surface protrusion is provided for the purpose of comfort of the user [col.4 ll.21-28].
Therefore it would have been obvious to one having ordinary skill in the art to modify the body disclosed by Papouras to have a surface protrusion in accordance with the teachings of Good. This would be done for the purpose taught above.
Allowable Subject Matter
Claims 2 and 5 would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims, and to overcome the hereinabove double-patenting rejections.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach, among other features, a hand assist device for use with a medical device, comprising:
a recess configured to receive a handle of the endoscope such that the hand assist device is removably coupled to the handle, the recess extending from a proximal to a distal end of the hand assist device,
in proximal-distal order, a finger support, a palm support and a base support, and
(claim 2) wherein the base support projects radially outward from the central longitudinal axis of the body relative to the palm support portion and includes a curved, concave exterior surface facing away from the central longitudinal axis
OR
(claim 5) a locking part configured to receive an accessory instrument, wherein the locking part is c-shaped and protrudes radially.
Papouras et al. (USPN 8,092,373) teaches the above except for (claim 2) the curved, concave exterior surface or (claim 5) the locking part.
Dellis (USPN 4,785,495) teaches a device hand grip with the base support required above for claim 2.
Good et al. (USPN 5,353,474) teaches the above except for (claim 2) that the curved, concave exterior surface is included in the base support or (claim 5) the locking part.
Pusateri et al. (USPN 6,082,468) teaches a device hand grip with the base support required above for claim 2.
Goto et al. (US PGPUB 2004/0015050) teaches an endoscope accessory with a locking part as taught above, except the locking part protrudes from an entirely different device.
Sasaki et al. (US 2005/0065399) teaches a removable endoscope handle accessory with a locking part at taught above.
There is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sasaki et al. (US 2005/0065399)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON B FAIRCHILD/ Primary Examiner, Art Unit 3795
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