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 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 5-7 and 15-16 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 these claims generally, each claim recites a number of days “wear time adhesive”. As best understood by the examiner, this term does not have an accepted definition in the art. The examiner notes that the applicant provides a possible definition (see e.g. paragraph 35 of applicant’s specification), but this definition is only conditionally applied and therefore does not extend into the claims. The examiner will interpret these limitations as an intended result which does not substantively limit the claim scope.
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(s) 1, 5-8 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 6,242,665 to Malowaniec (Malowaniec hereinafter).
Regarding claim 1, Malowaniec teaches an on-body medical device (1) comprising a skin-facing surface (visible side in Fig. 1) and an adhesive layer (2) comprising a stronger adhesive (4) around the periphery and a weaker adhesive (3) within the periphery, wherein the stronger adhesive is as much as 16 (1600%) times as strong as the weaker adhesive (see col. 2, ln. 46-53).
Regarding claims 5-7, as best understood by the examiner, the adhesives taught by Malowaniec are suitable for wear for the claimed durations and therefore anticipate these claims.
Regarding claim 8, the bandage taught by Malowaniec is suitable for delivering medicaments, such as antibiotic ointments, which are applied thereto prior to placement on a patient.
Regarding claim 11, Malowaniec teaches a hole in the adhesive layer (at pad 5) and that the stronger adhesive (4) is positioned around a perimeter of the hole, spaced from the hole by the weaker adhesive layer (3).
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2011/0160654 to Hanson et al. (Hanson) in view of Malowaniec.
Regarding claim 1, Hanson teaches a medical device (12) comprising a skin-facing surface (22), and adhesive layer (paragraph 115) secured to the skin-facing surface. Hanson does not teach varying adhesive strength areas. Malowaniec teaches an on-body medical device (1) comprising a skin-facing surface (visible side in Fig. 1) and an adhesive layer (2) comprising a stronger adhesive (4) around the periphery and a weaker adhesive (3) within the periphery, wherein the stronger adhesive is as much as 16 (1600%) times as strong as the weaker adhesive (see col. 2, ln. 46-53). Malowaniec teaches that this provides decreased skin stress and pain (col. 2, ln. 6-21). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use stronger peripheral and weaker internal adhesives with the patch of Hanson in order to lessen skin stress and pain in the use thereof.
Regarding claim 2, Hanson teaches a needle (58) inserted into an opening in the skin of the patient (paragraph 101) and an opening in the adhesive (see Fig. 4) surrounding it.
Regarding claim 3, Hanson teaches that a stronger adhesive may be used around the needle site (paragraph 280).
Regarding claim 4, considering Hanson in light of Malowaniec, it would have been obvious to use a stronger (as taught by Hanson, paragraph 280) adhesive weaker than the perimeter adhesive (4 of Malowaniec) in order to maintain the decreased skin stress and pain of Malowaniec while reinforcing the needle stick itself.
Regarding claims 5-7, as best understood by the examiner, the adhesives taught by Hanson and Malowaniec are suitable for wear for the claimed durations and therefore anticipate these claims.
Regarding claim 8, Hanson teaches a medicament delivery device (12).
Regarding claim 9, Hanson teaches an insulin pump (12).
Regarding claim 10, Hanson teaches a surface (22) on a housing (20).
Regarding claim 11, Hanson teaches that a stronger adhesive may be used around the needle site (paragraph 280).
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2014/0323941 to Lee et al. (Lee) in view of Malowaniec.
Regarding claim 12, Lee teaches an on-body medical device (e.g. 500, 600) comprising a housing (601) having a skin-facing surface (500) and an adhesive layer (503) comprising islands (e.g. 107, see paragraph 24) devoid of the adhesive. Lee does not teach varying adhesive strength areas. Malowaniec teaches an on-body medical device (1) comprising a skin-facing surface (visible side in Fig. 1) and an adhesive layer (2) comprising a stronger adhesive (4) around the periphery and a weaker adhesive (3) within the periphery, wherein the stronger adhesive is as much as 16 (1600%) times as strong as the weaker adhesive (see col. 2, ln. 46-53). Malowaniec teaches that this provides decreased skin stress and pain (col. 2, ln. 6-21). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use stronger peripheral and weaker internal adhesives with the device of Lee in order to lessen skin stress and pain in the use thereof.
Regarding claim 13, as shown in Fig. 1, Lee teaches that the islands (107) are periodically spaced apart (by ridges 105).
Regarding claim 14, Lee teaches a grid (see Fig. 1).
Regarding claims 15-16, as best understood by the examiner, the adhesives taught by Malowaniec are suitable for wear for the claimed durations and therefore render these claims obvious.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson in view of Malowaniec as applied to claim 1 above, and further in view of Lee.
Hanson teaches a medical device (12) comprising a skin-facing surface (22), and adhesive layer (paragraph 115) secured to the skin-facing surface.
Hanson does not teach varying adhesive strength areas. Malowaniec teaches an on-body medical device (1) comprising a skin-facing surface (visible side in Fig. 1) and an adhesive layer (2) comprising a stronger adhesive (4) around the periphery and a weaker adhesive (3) within the periphery, wherein the stronger adhesive is as much as 16 (1600%) times as strong as the weaker adhesive (see col. 2, ln. 46-53). Malowaniec teaches that this provides decreased skin stress and pain (col. 2, ln. 6-21). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use stronger peripheral and weaker internal adhesives with the patch of Hanson in order to lessen skin stress and pain in the use thereof.
Hanson further does not teach islands of stronger adhesives, though Hanson teaches that a stronger adhesive may be used around the needle site (paragraph 280). Lee teaches islands (bumps 300) of silicone adhesive (paragraph 6) for attaching a medical device to the skin of a patient. Lee teaches that the use of such bumps allows for hydrocolloids to be exposed (paragraph 6) so as to improve skin health during use and reduce irritation on removal. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide the adhesive of Hanson as bumps as taught by Lee in order to improve health and reduce irritation. Thus provided, the adhesive of Malowaniec would surround the islands of Lee when both are applied to Hanson. As is shown by all three references, selection of adhesive strength and arrangement is a result effective variable determining the effect of the medical device on a user, in particular on the skin of the user. Accordingly, it would have been obvious to arrive at the claimed relative adhesive strengths as the mere optimization of the adhesive strengths chosen in the apparatus of Hanson (see MPEP 2144.05 II) to maximize user skin health and minimize pain.
Regarding claims 18-19, Lee teaches that the islands are spaced apart in a grid (see Fig. 3).
Regarding claim 20, Hanson teaches a needle (58) inserted into an opening in the skin of the patient (paragraph 101) and an opening in the adhesive (see Fig. 4) surrounding it.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 5 February 2026