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 .
Drawings
The drawings are objected to as failing to adequately use solid black lines. 37 CFR 1.84(a)(1) requires black ink to secure solid black lines and 37 CFR 1.84(l) states that every line must be durable, clean, black, sufficiently dense and dark, and uniformly thick and well-defined.
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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the drug injecting part being shorter than the light source transmitting part of claim 5 must be shown or the feature canceled from the claim. Presently, it appears that the drug injecting part is longer than the light source transmitting part. 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.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Claim Objections
Claims 2 and 4 are objected to because of the following informalities:
In claim 2, line 5, “to to the syringe…” should be changed to “to the syringe…”
In claim 4, line 2, “drug injecting pat…” should be changed to “drug injection part…”
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 limitations are at least: the light generating part in claim 1, the backflow prevention fixing part in claim 2; the drug injecting part and light source transmitting part in claim 3; and the head part of claim 11.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. For example, the light generating part is interpreted as a light source, the backflow prevention fixing part is interpreted as a valve or seal, the drug injecting part is interpreted as the portion of the 2-way connector that is attached to the syringe, the light source transmitting part is interpreted at the portion of the 2-way connector that receives the optical cable, and the head part is interpreted as the bottom end of the handle.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid 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 1-14 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.
All 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. For example, the overuse of the word “part” which is often considered as a nonce term invoking a 112 6th paragraph interpretation, the use of a term such as “invades” in claim 1 which is an awkward and non-idiomatic, and the lack of proper transitional phrases such as “configured to” which are typically used for functional limitations. Claims will be interpreted as best understood by the Examiner. At the minimum, Examiner suggests the deletion of all recitations of the term “part” to conform to proper U.S. practice.
Claim 2 recites “a first direction of the other end is connected to…” and “a second direction of the other end is connected to…” It is unclear how a “direction” can be connected to something. A “direction,” whether it be a first or second direction, is not structure. Since a direction is not structure, it cannot then be connected to a structure such as the injection needle or the syringe. Additionally, the 2-way connector part is described as having “one end” and an “other end,” however given the broadest reasonable interpretation, a “2-way connector part” does not inherently have two ends or two ends that may be opposed to each other. It is unclear how ends can be defined on structure which may or may not have ends at all since.
The “second direction” of claim 2, the “light source transmitting part” of claim 3, and the “light transmitting part” of claim 3 all seem to encompass the same structure. For the purpose of examination, at least the light source transmitting part and the light transmitting part will be considered the same structure.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2000-312719 to Ishizaka.
Regarding claim 1, Ishizaka teaches a portable light-guided injection device (Fig. 1) comprising a syringe part ([0017]), that injects drug, an injection needle part (1) that invades an affected portion and injects the drug into the body, a main body part (2) that connects the syringe part and the injection needle part to provide a drug transmitting path (path within 9) and has a light generating part ([0019], light source) configured to provide light to the affected portion; and an optical cable part (7) that transmits the light provided from the light generating part to the affected portion.
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.
Claims 2-6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ishizaka in view of U.S. Patent No. 3,556,086 to Gordon.
Regarding claim 2, Ishizaka teaches the portable light-guided injection device of claim 1 as shown above, Ishizaka further teaching the main body part includes a 2-way connector part (2) of which one end is connected to the injection needle part (Fig. 4), a first direction of the other end is connected to [[to]] the syringe part (9), and a second direction (10) of the other end is connected to the light generating part to provide a drug transmitting path and a light transmitting path (path within 10), a backflow prevention fixing part (see annotated figure below) that is coupled to an end of the 2-way connector part in the second direction to fix the optical cable part and prevent a backflow of the drug, and a main body housing (overall housing of the device Fig. 4) that accommodates, the 2-way connector part, and the backflow prevention fixing part in an inner space, but does not teach a main body housing accommodating the light generating part.
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Gordon teaches a main body housing (39/21/23) that accommodates a light generating part (column 2, lines 62-66). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing of Ishizaka to further accommodate the light source as taught by Gordon to yield the predictable result of providing the light source and providing additional convenience or portability. The optical cable of Ishizaka inherently has a light source in order to function but it is not explicitly shown, Gordon merely shows one example of such a light source which is necessary for operating optical cables in a form that provides convenience and portability.
Regarding claim 3, Ishizaka and Gordon teach the portable light-guided injection device of claim 2 as shown above, Ishizaka teaching the 2-way connector part includes a first connector part (portion between 1 and 2 in Fig. 4) that is connected to the injection needle part, a drug injecting part (right portion of 9 from where 9 and 10 bifurcate) that accommodates the drug injected from the syringe part and provides a drug transmitting path, and a light source transmitting part (portion surrounding backflow prevention fixing part) that accommodates the optical cable part inserted through the backflow prevention fixing part and provides a light transmitting part (10, see 112 rejection above for interpretation).
Regarding claim 4, Ishizaka and Gordon teach the portable light-guided injection device of claim 3, Ishizaka further teaching the drug injecting part and the light source transmitting part are formed to form an acute angle with each other (9 and 10 form an acute angle, Fig. 4).
Regarding claim 5, Ishizaka and Gordon teach the portable light-guided injection device of claim 3 as shown above, Ishizaka further teaching a length of the drug injecting part (the right portion of 9 from where 9 and 10 bifurcate) is formed shorter than a length of the light source transmitting part (the section of 10 from where 9 and 10 bifurcate including the connector to the right of 10 in Fig. 4).
Regarding claim 6, Ishizaka and Gordon teach the portable light-guided injection device of claim 3 as shown above, Ishizaka further teaching an inner diameter (diameter at the backflow prevention fixing part) of the light source transmitting part is formed smaller than an inner diameter of the drug injecting part (Fig. 4),
Regarding claim 13, Ishizaka and Gordon teach the portable light-guided injection device of claim 2 as shown above, Ishizaka further teaching the syringe part includes a syringe ([0017]), and a second connector part (3) that connects the syringe and the 2-way connector part.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ishizaka in view of Gordon as applied to claim 3 above, and further in view of U.S. Patent No. 4,974,580 to Anapliotis.
Regarding claim 7, Ishizaka and Gordon teach the portable light-guided injection device of claim 3 including the 2-way connector, but do not mention a material of opaque color.
Anapliotis teaches a material of opaque color (column 3, lines 61-63). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used material having an opaque color for the 2-way of connector of Ishizaka as taught by Anapliotis to prevent light from escaping when using optical fibers (column 3, lines 62-63).
Claims 8, 9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ishizaka in view of Gordon as applied to claim 2 above, and further in view of U.S. Patent Publication No. 2003/0112639 to Stack.
Regarding claim 8, Ishizaka and Gordon teach the portable light-guided injection device of claim 2 as shown above, but do not show all the details of the light generating part
Stack teaches a light source (30, Fig. 1) that generates light, a power supply part (36) that applies power to the light source, a switch part ([0013], on/off switch) that controls power supply by the power supply part; and a light source cap part (18) that is coupled to the light source to prevent scattering of the light source and aligns and fixes centers of the light source and the optical cable part (Fig. 1). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the light generating part of Stack into the device of Ishizaka to yield the predictable result of providing control for the light source in order to activate the optical fibers. Both Ishizaka and Stack incorporate the use of optical fibers to provide illumination, although Ishizaka is silent as to the details, Ishizaka inherently has a system of control in order for the optical fibers to operate. Stack merely shows an example of control system for the same application.
Regarding claim 9, Ishizaka, Gordon, and Stack teach the portable light-guided injection device of claim 8 as shown above, Stack further teaching at least one of a control board (32) that adjusts a voltage applied to the light source and heat sinks (34) that dissipate heat generated in the light source.
Regarding claim 14, Ishizaka, Gordon, and Stack teach the portable light-guided injection device of claim 8 as shown above, Stack further teaching the optical cable part is coupled to or separated from the light source cap part (18 is coupled to 22), and Ishizaka further teaching the optical cable part is inserted into the injection needle through the backflow prevention fixing part, the light source transmitting part, and the first connector part to transmit light to the affected portion (Fig. 4).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ishizaka in view of Gordon and Stack as applied to claim 8 above, and further in view of U.S. Patent No. 5,269,750 to Grulke et al. (“Grulke”).
Regarding claim 10, Ishizaka, Gordon, and Stack teach the portable light-guided injection device of claim 8 as shown above, but do not show the details of the switch part.
Grulke teaches a switch part (131) is formed in a plate shape (Fig. 4) located between a power supply part (121, Fig. 7) and a contact plate (145) to connect or disconnect between the power supply part and the contact plate. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the switch part of Grulke in the device of Ishizaka, Gordon, and Stack, to yield the predictable result of providing a switch to control power being directed to a light for activating an optical cable. Stack already discloses the general use of a switch part but does not give specific details, Grulke shows an example of a switch part for use in a similar application.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ishizaka in view of Gordon, Stack, and Grulke as applied to claim 10 above, and further in view of U.S. Patent No. 10,966,702 to Swift et al. (“Swift”).
Regarding claim 11, Ishizaka, Gordon, Stack, and Grulke teach the portable light-guided injection device of claim 10, Grulke further teaching the switch part includes a handle part (131’, Fig. 7) that protrudes to the outside of the main body housing and is configured to hold the switch portion to push and pull the switch portion, a head part (131) that extends from the handle part and is integrally formed, and inserted into the main body housing to be positioned between the power source part and the contact plate (Fig. 7), but does not show the connection hole.
Swift teaches a connection hole (column 8, line 37, opening in push-tab) that is formed in a partial region of a head part (118), and a power supply part (114) and a contact plate (112b) are connected to each other through the connection hole as the switch part moves (column 8, lines 25-39). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the head part of Grulke as taught by Swift to yield the predictable result of providing a means to connect and disconnect power from a contact plate. Both Swift and Grulke disclose switches for connecting and disconnecting power. Swift merely shows an alternative type of head part that would accomplish the identical function.
Regarding claim 12, Ishizaka, Gordon, Stack, Grulke, and Swift teach the portable light-guided injection device of claim 11 as shown above, Grulke further teaching a switch hole (132) is formed in the main body housing so that the handle part (131’) protrudes to the outside of the main body housing through the switch hole (Fig. 7), and a width of the handle part (width of 131’) is formed smaller than a width (width of 144 above 143 in Fig. 4) of the head part, the width of the handle part is formed smaller than a width of the switch hole (131’ must fit inside 132 so it is smaller), and the width of the head part is formed larger than the width of the switch hole (width of 144 above 143 is larger than hole 132).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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