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 .
Claim Objections
Claim 1 is objected to because of the following informalities: The phrases “in one array” on line 4 and “in the other array” on lines 4-5 should be amended to recite “in one of the arrays” and “in the other of the arrays” since these arrays have already been introduced on line 3. The term “the” in the phrase “the opposite direction” on line 4 should be replaced with the term “an” since this is the first time that this “opposite direction” is being introduced. The term “a” on line 5 should be replaced with the term “an” in order to be grammatically correct. The term “state” should be inserted after the term “undeployed” on line 8 in order to be grammatically correct. The term microneedle” should be inserted before the term “patch” on line 8 in order to maintain consistency in claim language. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: The term “the” should be inserted before the term “deformation” on line 2 since this “deformation” has already been introduced in claim 2. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: The term microneedle” should be inserted before the term “patch” on line 3 in order to maintain consistency in claim language. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: A hyphen should be inserted between the terms “non” and “return” in the phrase “a non return lock” on line 2 (resulting in the phrase “a non-return lock”) in order to be grammatically correct. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: A hyphen should be inserted between the first occurrence of the term “face” and the term “to” and between the term “to” and the second occurrence of the term “face” on line 6 (resulting in the phrase “face-to-face”) in order to be grammatically correct. The term “microneedle” should be inserted before the term “patch” on line 6 in order to maintain consistency in claim language. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Each occurrence of the term “patch” on lines 2 and 3 lacks an article preceding it and, therefore, the phrase “the microneedle” should be inserted before the term “patch” in each of these phrases in order to be grammatically correct and maintain consistency in claim language. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The phrases “in one array” on line 3 and “in the other array” on line 4 should be amended to recite “in one of the arrays” and “in the other of the arrays” since these arrays have already been introduced on line 3. The term “a” on line 6 should be replaced with the term “an” and the term “an” on line 6 should be replaced with the term “a” in order to be grammatically correct. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: A hyphen should be inserted between the terms “non” and “return” in the phrase “a non return lock” on lines 1-2 (resulting in the phrase “a non-return lock”) in order to be grammatically correct. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: A hyphen should be inserted between the first occurrence of the term “face” and the term “to” and between the term “to” and the second occurrence of the term “face” on lines 5-6 (resulting in the phrase “face-to-face”) in order to be grammatically correct. The term “microneedle” should be inserted before the term “patch” on line 6 in order to maintain consistency in claim language. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: Each occurrence of the term “patch” on lines 2 and 3 lacks an article preceding it and, therefore, the phrase “the microneedle” should be inserted before the term “patch” in each of these phrases in order to be grammatically correct and maintain consistency in claim language. 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 8-14 and 17-20 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.
Claim 8 recites the phrase “such as to facilitate unitary operation thereof”. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (see MPEP § 2173.05(d)). For the sake of examination, the limitation following the phrase is interpreted as being a part of the claimed invention. Accordingly, it is suggested to replace the phrase “such as” with the phrase “such that”.
Claim 9 recites “in which the actuator comprises a pair of first surfaces on the applicator which are displaceable relative to one another, and a pair of second surfaces each of which is secured to one of the arrays”.
Regarding the phrase, “and a pair of second surfaces”, the language of the claim appears to require the pair of second surfaces be a component of the actuator, but this contradicts the specification which sets forth that the second surfaces are a component of the microneedle patch. Because of the contradiction between the claim language and the specification, it is unclear how to interpret claim 9 in light of the specification. For the sake of examination, claim 9 is interpreted as reciting “and in which the system further comprises a pair of second surfaces”.
Regarding the phrase “each of which is secured to one of the arrays”, it is unclear as to whether the pair are secured to one array or if each one of the pair is secured to a different one of the arrays. For the sake of examination, the latter is the interpretation applied to the claims. Accordingly, it is suggested to amend claim 9 to recite “each of which is secured to a respective one of the arrays”.
Claims 10-14 and 17-20 are rejected due to their dependence on claim 9.
Claims 11 and 17 each recite “the pair of first surfaces are substantially parallel” and “the pair of second surfaces are substantially parallel and each of which is secured to one of the arrays”.
Regarding the phrases “the pair of first surfaces are substantially parallel” and “the pair of second surfaces are substantially parallel”, each of these phrases is incomplete because they do not set forth what the surfaces are substantially parallel to. For example, it is unclear if the two first surfaces are substantially parallel to each other or to another/other feature(s) and if the two second surfaces are substantially parallel to each other or to another/other feature(s). For the sake of examination, the first surfaces are interpreted as being substantially parallel to each other and the second surfaces are interpreted as being substantially parallel to each other. Accordingly, it is suggested to amend claims 11 and 17 to each recite “the pair of first surfaces are substantially parallel to each other” and “the pair of second surfaces are substantially parallel to each other”.
Regarding the phrase “and each of which is secured to one of the arrays”, it is unclear as to whether the pair are secured to one array or if each one of the pair is secured to a different one of the arrays. For the sake of examination, the latter is the interpretation applied to the claims. Accordingly, it is suggested to amend claims 11 and 17 to each recite “and each of which is secured to a respective one of the arrays”.
Claims 12-14 and 18-20 are rejected due to their dependence on claims 11 and 17.
Claims 12 and 18 each introduce “at least one key” and “a corresponding keyway”. As written, claims 12 and 18 allow for more than one key (“at least one key”) but appear to only allow for one keyway (“a corresponding keyway”). It is unclear if these claims where intended to require one “keyway” that can interact with multiple “keys” or if these claims were intended to require a corresponding “keyway” for each of multiple “keys”. For the sake of examination, claims 12 and 18 are interpreted as requiring a “keyway” for each “key”. Accordingly, it is suggested to amend claims 12 and 18 to recite “in which the coupling comprises at least one key on the applicator or [the] patch and [[a]] at least one corresponding keyway on the other of the applicator or [the] patch within and along which the at least one key is slidably and releasably captured”.
Similarly, claims 13, 14, 19 and 20 each recite “the keyway” and should be amended to recite “the at least one keyway”.
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 1-3, 6-15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garvin et al. (PG PUB 2007/0021779).
Re claim 1, Garvin discloses a microneedle patch application system (as seen in Fig 9a,9b; it is noted that all reference characters cited below refer to Fig 9a,9b unless otherwise noted) comprising a microneedle patch 100+100 (seen in Fig 9a,9b but also seen in detail in Fig 4-8) for deployment on a tissue substrate (“for connecting wound tissue”, Para 70) and an applicator 142 operable to deploy the microneedle patch onto said substrate (Para 78); wherein the microneedle patch comprises two sets of microneedle arrays 114 (one set of microneedle arrays 114 is located on the left strap 100 of Fig 9a and a second set of microneedle arrays 114 is located on the right strap 100 of Fig 9a) with the microneedles in one array pointed in generally the opposite direction to the microneedles in the other array (as seen in Fig 9a), the arrays being displaceable relative to one another between a undeployed state (the “undeployed state” being when the proximal ends 108 of the straps 100,100 are facing each other but the ratchets 136 are not connected to each other as described in Para 76) and a deployed state (seen in Fig 5-8, when all of the rows of ratchets 136 are engaged as described in Para 76); a coupling (formed by both slots 140 of the microneedle patch and both hooks 152 of the applicator, Para 78) operable to releasably retain the microneedle patch on the applicator (Para 78); and an actuator (formed by finger slots 144 and 146, Para 78) operable to affect displacement of the microneedle arrays from the undeployed to the deployed state when the patch is retained on the applicator (Para 78).
Re claim 2, Garvin discloses that the applicator is deformable (via hinged joint 148, Para 78) and said deformation affects operation of the actuator and/or the coupling (because the deformation via hinged joint 148 causes the slots 144 and 146 of the actuator to move relative to each other and causes the left portion 140+152 and the right portion 140+152 of the coupling to move relative to each other, Para 78).
Re claim 3, Garvin discloses that the applicator comprises a first portion (the arm 150 directly connected to slot 144) and a second portion (the arm 150 directly connected to slot 146) and deformation of the applicator is affected by relative displacement between the first and second portions (Para 78).
Re claim 6, Garvin discloses that the applicator is manually deformable (via finger slots 144,146, Para 78).
Re claim 7, Garvin discloses that the applicator is operable such that actuation of the actuator affects actuation of the coupling (because the deformation via hinged joint 148 of the applicator causes the left portion 140+152 and the right portion 140+152 of the coupling to move relative to each other, Para 78).
Re claim 8, Garvin discloses that the coupling and the actuator are integrated with one another such as to facilitate unitary operation thereof (via arms 150, as seen in Fig 9a,9b and Para 78).
Re claim 9, Garvin discloses that the actuator comprises a pair of first surfaces (the surface of the left hook 152 facing to the right in Fig 9a (and engaging with the “second surface” on the left in Fig A below) and the surface of the right hook 152 facing to the left in Fig 9a (and engaging with the “second surface” on the right in Fig A below) on the applicator which are displaceable relative to one another (Para 78), and a pair of second surfaces (the surface of the left slot 140 facing to the left and the surface of the right slot 140 facing to the right in Fig 6 and labeled in annotated Fig A below) each of which is secured to one of the arrays (as seen in Fig 6,8), the second surfaces being engageable with and displaceable by the first surfaces (Para 78).
PNG
media_image1.png
439
597
media_image1.png
Greyscale
Re claim 10, Garvin discloses that the pair of first surfaces are displaceable relative to one another by means of a linear translation and/or a rotational translation of the pair of first surfaces (via hinged joint 148, Para 78).
Re claim 11, Garvin discloses that the pair of first surfaces are substantially parallel and displaceable relative to one another in a direction oblique to the first surfaces (based on the arrangement seen in Fig 9a,9b), the pair of second surfaces are substantially parallel and each of which is secured to one of the arrays (as seen in Fig 6,8), the second surfaces being displaceable relative to one another in a direction oblique to the second surfaces (Para 78), the first and second surfaces being in face to face engagement when the patch is retained on the applicator (as seen in Fig 9a,9b).
Re claim 12, Garvin discloses that the coupling comprises at least one key 152 (“hook”, Para 78) on the applicator and a corresponding keyway 140 (“slot”, Para 78) on the patch within and along which the at least one key is slidably and releasably captured (Para 78).
Re claim 13, Garvin discloses that the keyway is at least partially defined by one of the second surfaces (as seen in Fig 8 and Fig A above).
Re claim 14, Garvin discloses that the key is releasable from the keyway following a predetermined relative displacement of the first surfaces relative to the second surfaces (based on the arrangement seen in Fig 9a,9b, release is by movement of the first surfaces away from each other, Para 78).
Re claim 15, Garvin discloses a method of applying a microneedle patch to a tissue substrate (“process of engaging the tissue-connecting strap 100”, Para 76) comprising the steps of releasably securing a microneedle patch 100+100 (Fig 4-9b) to an applicator 142 (Fig 9a,9b), the patch comprising two sets of microneedle arrays 114 (one set of microneedle arrays 114 is located on the left strap 100 of Fig 9a and a second set of microneedle arrays 114 is located on the right strap 100 of Fig 9a) with the microneedles in one array pointed in generally the opposite direction to the microneedles in the other array (as seen in Fig 9a); pressing the arrays of microneedles against the tissue substrate (“inserted into the skin layer”, Para 76); utilizing the applicator to displace the pair of arrays relative to one another between a undeployed state (the “undeployed state” being when the proximal ends 108 of the straps 100,100 are facing each other but the ratchets 136 are not connected to each other as described in Para 76) and an deployed state (seen in Fig 5-8, when all of the rows of ratchets 136 are engaged as described in Para 76) such as to at least partially embed the microneedles in the tissue substrate (“the hooks 152 of the engagement tool 142 grasp each tissue-connecting strap 100 at the tool engagement slot 140 in order to close the tissue-connecting straps 100 upon each other”, Para 78); and releasing the actuator from the patch (Para 78).
Re claim 17, Garvin discloses that the pair of first surfaces are substantially parallel and displaceable relative to one another in a direction oblique to the first surfaces (based on the arrangement seen in Fig 9a,9b), the pair of second surfaces are substantially parallel and each of which is secured to one of the arrays (as seen in Fig 6,8), the second surfaces being displaceable relative to one another in a direction oblique to the second surfaces (Para 78), the first and second surfaces being in face to face engagement when the patch is retained on the applicator (as seen in Fig 9a,9b).
Re claim 18, Garvin discloses that the coupling comprises at least one key 152 (“hook”, Para 78) on the applicator and a corresponding keyway 140 (“slot”, Para 78) on the patch within and along which the at least one key is slidably and releasably captured (Para 78).
Re claim 19, Garvin discloses that the keyway is at least partially defined by one of the second surfaces (as seen in Fig 8 and Fig A above).
Re claim 20, Garvin discloses that the key is releasable from the keyway following a predetermined relative displacement of the first surfaces relative to the second surfaces (based on the arrangement seen in Fig 9a,9b, release is by movement of the first surfaces away from each other, Para 78).
Claim Rejections - 35 USC § 103
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.
Claims 4, 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Garvin et al. (PG PUB 2007/0021779) in view of Khouri et al. (PG PUB 2020/0367889).
Re claims 4 and 16, Garvin discloses all the claimed features except a lock operable to prevent relative displacement of the first and second portions until a threshold pressure is applied to the applicator from the patch (as required by claim 4) and a non-return lock operable to prevent the first and second portions from undergoing relative displacement once the arrays have been displaced into the deployed state (as required by claim 16). Khouri, however, teaches an applicator 100 (Fig 3A, wherein the applicator is formed of all components shown in Fig 3A except for the arrays 140,140) substantially similar to that of Garvin (in that, like Garvin, Khouri’s applicator includes two handles 110,120 attached to each other at a pivot point 115 with an actuator 112,112 at a proximal end a coupling 144,144 at a distal end) that comprises a first portion 110 and a second portion 120 that undergo relative displacement therebetween (Para 47), a lock 130 (“ratchet” comprising “ratchet teeth 132” and “ratchet catch 134”, Para 47) operable to prevent relative displacement of the first and second portions until a threshold pressure is applied to the applicator from the arrays (Para 47), and a non-return lock (the mechanism disclosed in Para 47 as causing the engagement of the ratchet catch 134 and the ratchet teeth 132 to “be locked”) operable to prevent the first and second portions from undergoing relative displacement once the arrays have been displaced into the deployed state (Para 47); Khouri teaches that providing both locks allows for the distance between the two sets of arrays 140,140 to be flexibly adjusted, stopped at a desired position during the adjustment, and locked when the two sets of arrays 140,140 are at a desired distance relative to each other (Para 47). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garvin to include a lock operable to prevent relative displacement of the first and second portions until a threshold pressure is applied to the applicator from the patch and a non-return lock operable to prevent the first and second portions from undergoing relative displacement once the arrays have been displaced into the deployed state, as taught by Khouri, for the purpose of allowing for the distance between the two assays to be flexibly adjusted, stopped at a desired position during the adjustment, and locked when the two sets of arrays are at a desired distance relative to each other (Para 47).
Re claim 5, Garvin discloses all the claimed features except a non-return lock operable to prevent the first and second portions from undergoing relative displacement once the arrays have been displaced into the deployed state. Khouri, however, teaches an applicator 100 (Fig 3A, wherein the applicator is formed of all components shown in Fig 3A except for the arrays 140,140) substantially similar to that of Garvin (in that, like Garvin, Khouri’s applicator includes two handles 110,120 attached to each other at a pivot point 115 with an actuator 112,112 at a proximal end a coupling 144,144 at a distal end) that comprises a first portion 110 and a second portion 120 that undergo relative displacement therebetween (Para 47) and a non-return lock (the mechanism disclosed in Para 47 as causing the engagement of the ratchet catch 134 and the ratchet teeth 132 of ratchet 130 to “be locked”) operable to prevent the first and second portions from undergoing relative displacement once the arrays have been displaced into the deployed state (Para 47) for the purpose of allowing the distance between the two sets of arrays 140,140 to be locked when the two sets of arrays 140,140 are at a desired distance relative to each other (Para 47). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Garvin to include a non-return lock operable to prevent the first and second portions from undergoing relative displacement once the arrays have been displaced into the deployed state, as taught by Khouri, for the purpose of allowing for the distance between the two assays to be locked when the two sets of arrays are at a desired distance relative to each other (Para 47).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat 1,868,100 to Goodstein, 3,068,870 to Levin, and PG PUB 2020/0205828 to Kawaura et al. each read on the system of at least independent claims 1 and 15.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783