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 of Invention I, claims 1-13, in the reply filed on 7/21/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). A mere broad allegation that the requirement is in error (i.e. the applicant disagrees with the restriction requirement) does not comply with the requirement of 37 CFR 1.111. Thus, the required provisional election (see MPEP § 818.01(b)) becomes an election without traverse if accompanied by an incomplete traversal of the requirement for restriction.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the center of the anus” in line 8 which should read “a center of an anus” for consistency purposes. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Claim 3 recites “the beginning” in line 2 which should read “a beginning”. Claim 3 is missing a period at the end of the sentence. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: Claim 5 recites “the glutes of a person” in line 2 which should read “glutes of the person” and “a colonoscopy procedure” in line 3 which should read “the colonoscopy procedure”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Claim 8 recites “the center of the anus” in line 8 which should read “a center of an anus” for consistency purposes. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 10 recites “the beginning” in lines 1-2 which should read “a beginning”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 recites “the glutes of a person” in lines 1-2 which should read “glutes of the person” and “a colonoscopy procedure” in line 3 which should read “the colonoscopy procedure”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, 6, 9, 11 and 13 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 2 and 9, the phrase "or other equivalent material" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or other equivalent material"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Regarding claim 4 and 11, the phrase "or other equivalent attachment means" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or other equivalent attachment means"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 6 recites the limitation "the amount of water and air/carbon dioxide" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the device" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the device” has been interpreted to read “the patch”.
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.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beran (US 4,516,293).
Regarding claim 1, Beran discloses a device (holder 10; Fig. 1) capable of air retention (via adhesion of strap arms 18, 19, 20, 21 around a body opening) comprising: a first end (at latch post 32); a second end (distal free end of strap 44) located at a distal end of the first end (Fig. 2); wherein the first end and the second end further include means of attachment (interpreted under 112(f) as an adhesive, Velcro or other equivalent attachment means and the conformation 46 on the strap into which the latch 40 will spring if the strap is moved leftward in Fig. 7 is considered an equivalent means) for attaching a back surface (surface of 44 containing 46) of the second end to a front surface (surface of 32 comprising latch 40) of the first end (Figs. 2-4); and wherein the second end (free end of 44) of the air retention device is shaped and configured to be pulled and stretched away from the first end (via pulling on the free end as shown in Fig. 4) such that the device can be wrapped around a central axis (axis through tube 12) which may be aligned with the center of the anus of a person and attached to the first end (as 32 attaches to 44; Figs. 1-4) for a colonoscopy procedure (as the holder 10 may be used around a colonoscope via user manipulation which is equivalent to tube 12).
Regarding claim 2, Beran discloses where the device is made of a silicone or other equivalent material that can be shaped and configured to allow flexibility during the colonoscopy procedure (as at least post 32 and strap 44 can be formed of resilient material, which is flexible; therefore, considered an equivalent material to silicone; column 4, lines 29-39; column 5, lines 32-35).
Regarding claim 3, Beran discloses wherein the device can be applied at the beginning and/or during the colonoscopy procedure (due to the slotted opening between strap arms 18 and 22, the holder 10 may be applied before or after tube 12 is inserted therethrough).
Regarding claim 4, Beran discloses wherein the means of attachment comprises of adhesive, Velcro or other equivalent attachment means (the conformation 46 on the strap into which the latch 40 will spring if the strap is moved leftward in Fig. 7 is considered an equivalent means).
Regarding claim 5, Beran discloses wherein the device can be placed on the gluteus of a person (via adhesive material on section 14 which adheres to a patient’s skin; column 3, lines 58-61) and tightened around a colonoscope (tube 12) such that there will be no need to remove the colonoscope during a colonoscopy procedure (Fig. 1).
Regarding claim 6, Beran discloses wherein the usage of the device can reduce the amount of water and air/carbon dioxide during the colonoscopy procedure (via user’s manipulation of the device and adhering the section 14 around the anus to block fluid therefrom).
Regarding claim 7, Beran discloses wherein the device can be manufactured for both a smaller size and a larger size patient (due to the adjustable holder, the device can be used to hold tubes that have any number of sizes, accommodating both a smaller size and a larger size patient; column 1, lines 65-67).
Regarding claim 8, Beran discloses a patch (holder 10 which includes adhesive section 14; therefore, considered a patch; Fig. 1) comprising a first end (at latch post 32); a second end (distal free end of strap 44) located at a distal end of the first end (Fig. 2); wherein the first end and the second end further include means of attachment (interpreted under 112(f) as an adhesive, Velcro or other equivalent attachment means and the conformation 46 on the strap into which the latch 40 will spring if the strap is moved leftward in Fig. 7 is considered an equivalent means) for attaching a back surface (surface of 44 containing 46) of the second end to a front surface (surface of 32 comprising latch 40) of the first end (Figs. 2-4); and wherein the second end (free end of 44) of the patch is shaped and configured to be pulled and stretched away from the first end (via pulling on the free end as shown in Fig. 4) such that the patch can be wrapped around a central axis (axis through tube 12) which may be aligned with the center of the anus of a person and attached to the first end (as 32 attaches to 44; Figs. 1-4) for a colonoscopy procedure (as the holder 10 may be used around a colonoscope via user manipulation which is equivalent to tube 12).
Regarding claim 9, Beran discloses where the patch is made of a silicone or other equivalent material that can be shaped and configured to allow flexibility during the colonoscopy procedure (as at least post 32 and strap 44 can be formed of resilient material, which is flexible; therefore, considered an equivalent material to silicone; column 4, lines 29-39; column 5, lines 32-35).
Regarding claim 10, Beran discloses wherein the patch can be applied at the beginning and/or during the colonoscopy procedure (due to the slotted opening between strap arms 18 and 22, the holder 10 may be applied before or after tube 12 is inserted therethrough).
Regarding claim 11, Beran discloses wherein the means of attachment comprises of adhesive, Velcro or other equivalent attachment means (the conformation 46 on the strap into which the latch 40 will spring if the strap is moved leftward in Fig. 7 is considered an equivalent means).
Regarding claim 12, Beran discloses wherein the patch can be placed on the gluteus of a person (via adhesive material on section 14 which adheres to a patient’s skin; column 3, lines 58-61) and tightened around a colonoscope (tube 12) such that there will be no need to remove the colonoscope during a colonoscopy procedure (Fig. 1).
Regarding claim 13, Beran discloses wherein the patch can be manufactured for both a smaller size and a larger size patient (due to the adjustable holder, the device can be used to hold tubes that have any number of sizes, accommodating both a smaller size and a larger size patient; column 1, lines 65-67).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Karim et al. (US 2019/0030288 A1) is noted for teaching silicon adhesive patches, Göransson (US 2010/0057010 A1) is noted for teaching a silicone section (4) for holding a tube, and Gentelia et al. (US 5,135,506) is noted for teaching an adhesive patch that may be wrapped around a tube similar to the device claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771