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 .
This action is in response to the non-provisional application filed on 06/11/2025. Claims 1-7 are pending. Claim 1 is independent.
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.
Currently, none of the claims are interpreted under 35 U.S.C. 112(f).
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, 2, and 4-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Teaque (US Pub. No.: 2007/0213634).
Regarding claims 1, 2, and 4-6, Teaque discloses [claim 1] a lymphangiogenesis inducing device comprising: a puncture member (114, Fig. 1B) comprising a distal end portion (distal end of 114, Fig. 1B and Para. [0063], 114 include a sharpened distal end) configured to puncture living tissue, and a through hole (central lumen or through hole of 114, Fig. 1B and also see 3C) penetrating the puncture member along a central axis and extending from the distal end portion toward a proximal end (see Figs. 1B, 2B, and 3C); and a rod-shaped body (101, Fig. 5A and 5B) inserted into the through hole and configured to be moved so as to protrude from the distal end portion (Para. [0035] and also see Fig. 3C), wherein: the rod-shaped body comprises a shaft portion (shaft or tube portion of 101, Fig. 4A), and a wound imparting structure (barbs 108, Figs 5A and 5B) comprising at least one protrusion (barbs 108, Figs. 5A and 5B) located on the shaft portion and configured to impart a wound to the living tissue (Paras. [0035] and[0036], the barbs 108 are fully capable to impart a wound to the living tissue because they are configured to cut tissue), the at least one protrusion has a protruding height from the shaft portion that increases when the at least one protrusion transitions from a state in which the at least one protrusion is located in the through hole to a state in which the at least one protrusion is located outside the through hole (Paras. [0034]-[0036] and also see Figs. 3C and 3B as an illustrative example), and the at least one protrusion protrudes in a direction perpendicular to the central axis when in the state in which the at least one protrusion is outside the through hole (Fig. 5B and Para. [0035], the barbs are perpendicular to the central axis because they are perpendicular to outer surface 106 of 101); [claim 2] wherein: the at least one protrusion is folded inward when in the state in which the at least one protrusion is located in the through hole (Paras. [0034]-[0036] and also see Figs. 3C and 3B as an illustrative example), and opens outward and protrudes in the direction perpendicular to the central axis when in the state in which the at least one protrusion is outside the through hole (Fig. 5B and Para. [0035], the barbs are perpendicular to the central axis because they are perpendicular to outer surface 106 of 101); [claim 4] wherein: the at least one protrusion comprises a plurality of protrusions that protrude in directions perpendicular to the central axis when in the state in which the protrusions are located outside the through hole (Fig. 5B); [claim 5] wherein: the plurality of protrusions comprises protrusions located at different axial positions and different circumferential positions of the shaft portion (Fig. 5B); [claim 6] wherein: the protrusions are folded inward when in the state in which the protrusions are located in the through hole (Paras. [0034]-[0036] and also see Figs. 3C and 3B as an illustrative example), and open outward and protrude in directions perpendicular to the central axis when in the state in which the protrusions are outside the through hole(Fig. 5B and Para. [0035], the barbs are perpendicular to the central axis because they are perpendicular to outer surface 106 of 101).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brugge (US Pub. No.: 2005/0256426) in view of Gilbert (US Pub. No.: 2020/0305851).
Regarding claim 1, Brugge discloses a device (10, the device 10 of Brugge is fully capable to serve as a lymphangiogenesis inducing device because it is for piercing through tissue with the bristles) comprising: a puncture member (12, Fig. 1) comprising a distal end portion (20, Fig. 1-1B and Para. [0027]) configured to puncture living tissue, and a through hole (central lumen or through hole of 12, Figs. 1-1B) penetrating the puncture member along a central axis and extending from the distal end portion toward a proximal end; and a rod-shaped body (22, Figs. 1-1B) inserted into the through hole and configured to be moved so as to protrude from the distal end portion, wherein: the rod-shaped body comprises a shaft portion (shaft portion of 22, Figs. 1-1B) , and a wound imparting structure (bristles 22a, Figs. 1-1B and Para. [0029]) comprising at least one protrusion (bristles 22a, Figs. 1-1B and Para. [0029]) located on the shaft portion and configured to impart a wound to the living tissue. However, Brugge does not disclose that the at least one protrusion has a protruding height from the shaft portion that increases when the at least one protrusion transitions from a state in which the at least one protrusion is located in the through hole to a state in which the at least one protrusion is located outside the through hole, and the at least one protrusion protrudes in a direction perpendicular to the central axis when in the state in which the at least one protrusion is outside the through hole.
Gilbert teaches, in the same field of endeavor (tissue sampling), at least one protrusion (bristles, Fig. 3B) has a protruding height from the shaft portion that increases when the at least one protrusion transitions from a state in which the at least one protrusion is located in the through hole (Fig. 2B) to a state in which the at least one protrusion is located outside the through hole (Fig. 3B), and the at least one protrusion protrudes in a direction perpendicular to the central axis when in the state in which the at least one protrusion is outside the through hole (Figs. 3B and 10A and Paras. [0077] and [0081]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the device of Brugge to include the at least one protrusion has a protruding height from the shaft portion that increases when the at least one protrusion transitions from a state in which the at least one protrusion is located in the through hole to a state in which the at least one protrusion is located outside the through hole, and the at least one protrusion protrudes in a direction perpendicular to the central axis when in the state in which the at least one protrusion is outside the through hole as taught by Gilbert in order to minimize the radial delivery profile of the overall device to facilitate the insertion of the device while maximizing the overall radial deployed profile of the protrusion.
Regarding claim 2, Gilbert discloses that the at least one protrusion is folded inward when in the state in which the at least one protrusion is located in the through hole (Fig. 2B), and opens outward and protrudes in the direction perpendicular to the central axis when in the state in which the at least one protrusion is outside the through hole (Figs. 3B and 10A and Paras. [0077] and [0081]).
Regarding claim 3, Gilbert discloses that the at least one protrusion is folded inward toward a proximal end of the rod-shaped body when in the state in which the at least one protrusion is located in the through hole (Fig. 2 and Para. [0077]), and opens outward and protrudes in the direction perpendicular to the central axis when in the state in which the at least one protrusion is outside the through hole (Figs. 3B and 10A and Paras. [0077] and [0081]).
Regarding claim 4, Gilbert discloses that the at least one protrusion comprises a plurality of protrusions that protrude in directions perpendicular to the central axis when in the state in which the protrusions are located outside the through hole (Figs. 3B and 10A and Paras. [0077] and [0081]).
Regarding claim 5, Brugge discloses that the plurality of protrusions comprises protrusions located at different axial positions and different circumferential positions of the shaft portion (Figs. 1-1B).
Regarding claim 6, Gilbert discloses that the protrusions are folded inward when in the state in which the protrusions are located in the through hole (Fig. 2 and Para. [0077]), and open outward and protrude in directions perpendicular to the central axis when in the state in which the protrusions are outside the through hole (Figs. 3B and 10A and Paras. [0077] and [0081]).
Regarding claim 7, Gilbert discloses that the protrusions are folded inward toward a proximal end of the rod-shaped body when in the state in which the protrusions are located in the through hole (Fig. 2 and Para. [0077]), and open outward and protrude in directions perpendicular to the central axis when in the state in which the protrusions are outside the through hole (Figs. 3B and 10A and Paras. [0077] and [0081]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20140039346 A1 Gillespie; Alexandra J. discloses a device having bristles for collecting tissue sample.
US 20150065915 A1 Jafri; Farrukh M. discloses an endobrush with receptable
US 5713369 A Tao; Liang-Che et al. discloses an uterine endometrial tissue sample brush
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/JING RUI OU/ Primary Examiner, Art Unit 3771
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