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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Netherlands on 24 October 2017. It is noted, however, that applicant has not filed a certified copy of the NL2019790 application as required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: Applicant is requested to amend the first paragraph of the specification to indicate that parent application 16/844,491 is now U.S. Patent No. 11,654,026.
Appropriate correction is required.
Claim Objections
Claims 1, 8, 9, and 13-15 are objected to because of the following informalities:
In claim 1, line 3: there should apparently be a semi-colon following “sheath”.
In claim 8, line 4: “the second configuration” should apparently read --the second non-tensioned configuration--.
In claim 9, line 6: “the first configuration” should apparently read --the first tensioned configuration--.
In claim 13, line 1: “Method” should apparently read --A method--.
In claim 13, line 3: “tensioned configuration” should apparently read --first tensioned configuration--.
In claim 13, line 4: the comma following “release member” should apparently be deleted.
In claim 14, line 1: “Method” should apparently read --The method--.
In claim 15, line 1: “Method” should apparently read --The method--.
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.
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: “a bias member” and “a release member” in claim 1, as well as “a centering member” in claim 10. The bias member is taught to be a spring member/element. The release member is not taught to be any specific structure. The centering member is taught to be an elongate member that defines a lumen.
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 § 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 1-15 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 claim 1, the phrase "for example" (in line 1) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the claimed implant must be a penis implant. For the sake of compact prosecution, the claimed implant will be taken herein to comprise a penis implant.
Also regarding claim 1, as detailed supra, claim limitation “a release member” 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. No structure is taught for this component, beyond including an engagement portion and an activation portion (which suffer the same deficiencies). 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 2, the phrase "preferably" (in line 5) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the cable member must be coupled to the first and second end portions of the sheath via first and second crimp members.
Claim 3 recites the limitation “a bias” in line 1. It is not clear if this is intended to refer to the same bias recited in line 8 of claim 1 or to be a separate bias.
Also regarding claim 3, the phrase "preferably" (in line 3) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the bias member must be a spring element.
Regarding claim 9, the phrase "preferably" (in line 3 and twice in line 4) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the slots must be non-linear or linear, if the slots must define a pattern of openings, or if the slots are configured to engage each other and lock into place.
Regarding claim 10, the phrase "preferably" (in line 3) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the cable member must be disposed within a lumen of the centering member.
Claim 11 recites the limitations "the first end portion" in lines 1-2 and “the second end portion” in lines 2-3. There is insufficient antecedent basis for these limitations in the claim.
Claim 12 recites the limitations “the cable element” in line 1 and "the tensioned and non-tensioned configurations" in lines 2-3. There is insufficient antecedent basis for these limitations in the claim. The cable element has been taken herein to be the same as the cable member, while the tensioned and non-tensioned configurations have been taken herein to refer to the first tensioned configuration and the second non-tensioned configuration.
Claim 13 recites the limitations “a first, tensioned configuration” in lines 1-2 and “a second, non-tensioned configuration” in line 2. It is not clear if these are intended to refer to the first tensioned configuration and second non-tensioned configuration recited in claim 1 or to be separate configurations.
Claim 13 also recites the limitation "the release members" in line 6. There is insufficient antecedent basis for this limitation in the claim. Only a single release member has been previously recited. It is noted that if this limitation is amended, the subsequent recitation of “these no longer protrude” may also need to be amended in kind; claims 14 and 15 also both recite “release members” and may also need to be amended in kind.
Claim 14 recites the limitations "the plunger member" in line 2 and “the first end portion” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 14 also recites the limitation “whereby the release members age the plunger member” in line 4. It is not clear what is meant by “age” in this limitation. Based upon the specification, this appears to be a typographical error and should instead read --engage--.
Claim 14 also recites the limitation "the cable" in line 5. There is insufficient antecedent basis for this limitation in the claim. This has been taken herein to refer to the cable member.
Claim 15 recites the limitations "the plunger member" in lines 2-3 and “the second end portion” in lines 3-4. There is insufficient antecedent basis for these limitations in the claim.
Claims 2-15 are rejected by virtue of their dependence upon at least one rejected base claim.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-15 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-15 of prior U.S. Patent No. 10,653,525. This is a statutory double patenting rejection.
Allowable Subject Matter
Claims 1-15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and if the double patenting rejections set forth in this Office action are overcome.
The following is a statement of reasons for the indication of allowable subject matter: while penis implants are known in the prior art (see all the references cited in the IDS filed 13 April 2023) that include tensioners for applying tension to a sheath so that the sheath can move between a first tensioned configuration and a second non-tensioned configuration, along with a release member, none of the prior art of record teaches such a release member that is accessible and operable through a window or opening in the sheath, wherein a portion of the release member is extendible through the window/opening, in combination with such a penis implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Branham, Sr. (U.S. Pub. No. 2015/0282977 A1) teaches an erection management system with a tension band assembly that includes a release cord that extends through holes of a restrictor sleeve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791