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 Invention 1 in the reply filed on November 10th 2025 is acknowledged. Claims 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the hook and the convex plate being matched with each other so as to allow the sheathed core to only move in the sheathed handle unidirectionally as described in the specification (¶[0009] of the published application). Figure 3 appears to show enough space between convex plates (5 and 6) such that the hook (4) could move axially in two directions at least when positioned between the plates as shown. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. The hook and the convex plate being matched with each other so as to allow the sheathed core to only move in the sheathed handle unidirectionally (claim 1, lines 4-6) must be shown or the feature(s) canceled from the claim(s). The additional main device (claim 11, lines 1-2) must be shown or this feature should be canceled from the claim. The “sheathed handle” and “sheathed core” are recited in claim 7 from which claim 11 depends. In paragraph [0018] of the published application, the main device is described as comprising these structures yet claim 11 recites the main device as an additional component to the sheathed handle and sheathed core recited in claim 7. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: “driving device”, “removing device” and “positioning device” in claim 11.
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 Objections
Claims 1, 2, 5, 7 and 12 are objected to because of the following informalities:
In line 2 of claim 1, “the inner wall” should read --an inner wall--.
In line 2 of claim 2, “of convex plate” should read --of the convex plate--.
In line 3 of claim 5, “the outer wall” should read --an outer wall--.
In line 1 of claim 6, “adopting” should read --comprising-- or --consisting of--.
In line 2 of claim 7, “of convex plate” should read --of the convex plate-- (see 112 rection of claim 6 below) or --of a convex plate--.
In lines 3-4 of claim 12, the should be deleted from “the front ends” and “the middle sections”.
Appropriate correction is required.
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 1-12 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. Consequently, numerous instances of indefiniteness rejectable under 35 USC 112 have been found and are listed here. However, more may exist and Applicant is strongly encouraged to thoroughly review the claims and correct them accordingly.
In line 5 of claim 2, it is unclear if the convex plate of claim 1 is one of the “convex plates”.
In line 3 of claims 5 and 10, the phrase "preferably" 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).
In line 5 of claim 7, there is insufficient antecedent basis for “convex plates”.
It is unclear if claim 6 comprises all of the limitations of claim 1 or not. The word “adopting” is not a recognized transitional phrase in current U.S. patent examination practice (MPEP 2111.03). Claims 7-12 are rejected at least due to their dependence from claim 6. For the purpose of this examination, claims 6-12 are interpreted as requiring all of the limitations of claim 1.
In lines 6-7 of claim 11, there is insufficient antecedent basis for “the prepuce positioned on the positioning device”.
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zheng (CN 1463677; see attached English translation).
Regarding claims 1 and 6, Zheng discloses an advancing and self-locking device (see drawing below for a depiction of the assembled device based on Zheng’s disclosure) or circumcision device (see “Double-ring circumcision device” in attached translated document), comprising a hook (see “hook” in drawing below) and a convex plate (see either “convex plate” in drawing below - either component labeled as such can be the convex plate while the other can be the first stage convex plate of claim 3; since Applicant’s second-stage convex plate 6 appears to be a ring with a polygonal cross-section and no obvious convex structure other than its interior corners - any circumferential structure having outward corners or protruding sides can be regarded as a convex plate), wherein the convex plate is arranged on the inner wall of a sheathed handle (see that the convex plate is on the “inner wall of the sheathed handle” in the drawing below); the hook is arranged on a sheathed core (see hook being on or connected to the “sheathed core” in the drawing below); the sheathed core is arranged in the sheathed handle (see the “sheathed handle” in drawing below - comprising all components pointed to by arrows) in a penetrating manner (it is partially within the handle); the hook and the convex plate are matched with each other (they are at least longitudinally matched or aligned with eachother; member 8 is shape matched to the hook as well) so as to allow the sheathed core to only move in the sheathed handle axially and unidirectionally (when member 9 of Zheng is moved up so that member 8 is pressed against 6 by the ledge on which it rests, and member 9 is held firm, the sheathed core could only move be moved axially and unidirectionally downward - ¶[0014]).
Regarding claims 2 and 7, a stage of convex plate is arranged on the inner wall of the sheathed handle (as explained above) in a movement direction of the sheathed core, thereby forming a locking position (any position of member 9 can be regarded as being in a movement direction of the sheathed core thereby forming a locking position - a locking position can be regarded as a position in which the sheathed core is capable of being locked by some means, the claims do not require the sheathed core to be locked to any other structure of the device in the locking position; however, member 9 can be moved up so that the convex plate 8 can lock within groove 5 - see step “5” in translation; any portion of the convex plate can be regarded as a stage of the convex plate as claimed).
Regarding claims 3 and 8, a first-stage convex plate (upper convex plate in above drawing in this interpretation) and a second-stage convex plate (see “second stage convex plate” in above drawing) are sequentially arranged on the inner wall of the sheathed handle in the movement direction of the sheathed core; a first locking position is formed at one side of the first-stage convex plate, which is close to the second-stage convex plate; a second locking position is formed at one side of the second-stage convex plate, which is away from the first-stage convex plate (any portion of either plate can be regarded as a locking position as claimed; being close to or away from the other plate; i.e. a locking position as claimed can be regarded as a position in which a structure is capable of being locked in place using some means or having something locked against it).
Regarding claims 4 and 9, a chamfer is arranged at one side of the first-stage convex plate (see beveled upper surface of upper convex plate in drawing above), which is away from the second-stage convex plate.
Regarding claims 5 and 10, a sleeve (see “sleeve of sheathed handle” in drawing above) is arranged in a region, which corresponds to a position where the convex plate is located, on the outer wall (portion pointed to by “10” in Figure 2) of the sheathed handle; preferably, the sleeve is rotatably arranged on the outer wall of the sheathed handle, thereby allowing or preventing the sheathed core to move or from moving in the sheathed handle axially and unidirectionally (the limitations following “preferably” are not required by the claim).
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 2013/0153630).
Regarding claims 1 and 6, Miller et al. disclose an advancing and self-locking device (10) or circumcision device (circular staplers being very similar in design and function to Applicant’s device could perform circumcision on at least some patient’s as evident from Figures 2A-2C; see knife 36), comprising a hook (any of teeth 322; Figure 8A; not that Applicant’s hook 4 is in the form of a similarly shaped tooth) and a convex plate (330 or 340 - both having rounded or convex edges), wherein the convex plate is arranged on the inner wall of a sheathed handle (302); the hook is arranged on a sheathed core (39 - it is at least within the sheathed handle and therefore is sheathed); the sheathed core is arranged in the sheathed handle (Figure 8A) in a penetrating manner; the hook and the convex plate are matched with each other (Figure 8B; ¶[0078]).
Miller et al. fail to disclose that the hook and the convex plate are matched with each other so as to allow the sheathed core to only move in the sheathed handle axially and unidirectionally.
Miller et al. disclose a similar lockout mechanism (Figures 12A and 12B) where a plate (730) is matched with a hook (722) as to allow the sheathed core to only move in the sheathed handle axially and unidirectionally (¶[0098]) so that a user may increase a distance between an anvil and stapling head.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the mechanism of Figures 8A and 8B with the one-way ratcheting function of Figures 12A and 12B so that a user may increase a distance between the anvil and stapling head if needed when in the locked-out state.
Regarding claims 2 and 7, a stage of the convex plate (any position of 330 or 340 in the locked state) is arranged on the inner wall of the sheathed handle in a movement direction of the sheathed core, thereby forming a locking position (¶[0078]).
Regarding claims 3 and 8, a first-stage convex plate (340) and a second-stage convex plate (330) are sequentially arranged on the inner wall of the sheathed handle (Figure 8B) in the movement direction of the sheathed core; a first locking position is formed at one side of the first-stage convex plate (side facing 330 in Figure 8B), which is close to the second-stage convex plate; a second locking position is formed at one side of the second-stage convex plate (e.g. at “332” in Figure 8B), which is away from the first-stage convex plate.
Regarding claims 4 and 9, a chamfer is arranged at one side of the first-stage convex plate, which is away from the second-stage convex plated (each tooth 322 has at least one chamfered side which is “at” a side of the plate 340 and away from 330 when engaged with 330).
Regarding claims 5 and 10, a sleeve (310; the trigger holds spring 78 in a sleeved manner - Figure 4A) is arranged in a region, which corresponds to a position where the convex plate is located, on the outer wall of the sheathed handle (evident from Figures 8A and 8B); preferably, the sleeve is rotatably arranged on the outer wall of the sheathed handle, thereby allowing or preventing the sheathed core to move or from moving in the sheathed handle axially and unidirectionally (the limitations following “preferably” are not required by the claim).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771