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 18 and 21 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 18 and 21 recite the limitation "tendon or ligaments" in line 3. There is insufficient antecedent basis for this limitation in the claim. claim 14, from which this claim depends recites “underlying tissue, muscle, or joints associated with the spine” with no mention of ligaments or tendons. For examination purposes, the limitation will be seen as referring to the recitation from claim 14, not including tendons or ligaments.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuzhakov (US 20080125743 A1) (noted on IDS) in view of Oronsky et al. (US 20100042137 A1) (noted on IDS).
Regarding claim 2, Yuzhakov discloses a method of using a device comprising:
a foundation (12) interconnecting a plurality of spring structures (18) (Figure 1-2; Paragraph 0024);
a backing (13) including an adhesive layer, the foundation affixed to the backing (Figure 1; Paragraph 0024); and
a plurality of microstructures (14) arrayed on the foundation (Figure 1; Paragraph 0024), each microstructure of the plurality of microstructures extending from the foundation adjacent to a spring structure of the plurality of spring structures (Figure 1; Paragraph 0017);
the method comprising:
applying the device to an area of skin adjacent underlying tissue (stratum corneum) (Paragraph 0003; 0018); and
penetrating each microstructure of the plurality of microstructures into the area of skin (Paragraph 0003; 0018; 0074).
Yuzhakov fails to explicitly disclose a method of reducing or preventing pain or inflammation comprising applying the device to an area of skin adjacent underlying tissue, muscle, joint, tendon, ligaments, or bursa to treat pain originating from the underlying tissue, muscle, joint, tendon, ligaments, or bursa.
However, Oronsky is directed to a drug delivery system and teaches a method of reducing or preventing pain or inflammation comprising applying the device (200+500) to an area of skin adjacent underlying tissue, muscle, joint or tendon to treat pain originating from the underlying tissue, muscle, joint or tendon (Paragraph 0011; 0026; 0051; 0062; 0111).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Yuzhakov such that the device is used in a method of reducing or preventing pain or inflammation comprising applying the device to an area of skin adjacent underlying tissue, muscle, joint, tendon, ligaments, or bursa to treat pain originating from the underlying tissue, muscle, joint, or tendon, as taught by Oronsky, as both references and the claimed invention are directed to drug delivery patches. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yuzhakov with the teachings of Oronsky by incorporating a method of reducing or preventing pain or inflammation comprising applying the device to an area of skin adjacent underlying tissue, muscle, joint, or tendon to treat pain originating from the underlying tissue, muscle, joint, or tendon in order to relieve pain or treat a specific medical condition (Oronsky Paragraph 0076) as, Yuzhakov discloses drug delivery but is silent to the specific drugs used and the treatment sites (Paragraph 0007; 0069).
Regarding claim 3, Oronsky further teaches wherein the device is applied directly over a painful area of the underlying tissue, muscle, joint, or tendon (Paragraph 0011; 0026; 0121-124).
Regarding claim 4, Oronsky further teaches wherein the device is applied over an area of a pathology that is causing the pain (Paragraphs 0121-124).
Regarding claim 5, Oronsky further teaches wherein the area of skin is a distance from the underlying tissue, muscle, joint, or tendon causing the pain (Paragraph 0132; 0134).
Regarding claim 6, Oronsky further teaches wherein the microstructure device remains on the skin for a period of one hour to one week (Paragraph 0062), which encompasses the claimed time frames of 1 hour to 10 days; 8 hours to 6 days; and one day to 5 days.
Regarding claim 7, the combination of Yuzhakov and Oronsky teaches wherein applying the device to the area of skin includes penetrating a range of two to 1,000 microstructures into the area of skin to treat pain generated by the underlying tissue, muscle, joint, or tendon (Figure 2A) (Figure 2A shows a plurality of microneedles in a range of 2 to 1000).
Regarding claim 8, Yuzhakov further discloses wherein the penetrating each microstructure of the plurality of microstructures into the area of skin includes insertion of each microstructure into an upper dermis layer of skin (Paragraph 0018; 0070).
Regarding claim 9, Yuzhakov further discloses wherein the applying the device to the area of skin includes adhering the adhesive layer of the backing to skin surrounding the area of skin (Paragraph 0049; 0052).
Regarding claim 10, Oronsky further teaches wherein the applying the device to the area of skin includes applying the device adjacent a joint to treat pain originating from arthritis in the joint (Paragraph 0011; 0120-134).
Regarding claim 11, Oronsky further teaches wherein the applying the device adjacent the joint is to treat pain originating from osteoarthritis (Paragraph 0011; 0111; 0165-166).
Regarding claim 12, Yuzhakov further discloses wherein the backing is a non-woven material (Paragraph 0040) (Paragraph 0040 lists a variety of preferred materials, including non-woven materials).
Regarding claim 13, Oronsky further teaches wherein the applying the device to the area of skin includes applying the device adjacent a portion of a neck of a patient to treat pain originating from underlying tissue, muscle, or joints of the neck (Paragraph 0147; 0152-153).
Regarding claim 14, Yuzhakov discloses a method of using a device comprising:
a foundation (12) interconnecting a plurality of spring structures (18) (Figure 1-2; Paragraph 0024);
a backing (13) including non-woven material and an adhesive layer, the foundation affixed to the backing (Figure 1; Paragraph 0024; 0040) (Paragraph 0040 lists a variety of preferred materials, including non-woven materials); and
a plurality of microstructures (14) arrayed on the foundation (Figure 1; Paragraph 0024), each microstructure of the plurality of microstructures extending from the foundation adjacent to a spring structure of the plurality of spring structures (Figure 1; Paragraph 0017);
the method comprising:
applying the device to an area of skin (Paragraph 0003; 0018); and
penetrating each microstructure of the plurality of microstructures into the area of skin (Paragraph 0003; 0018; 0074).
However, Oronsky teaches a method of reducing or preventing pain or inflammation comprising applying the device to an area of skin adjacent a spine of a patient to treat pain originating from underlying tissue, muscle, or joints associated with the spine (Paragraph 0011; 0161; 0163-164; 0230).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yuzhakov with the teachings of Oronsky by incorporating applying the device to an area of skin adjacent a spine of a patient to treat pain originating from underlying tissue, muscle, or joints associated with the spine in order to relieve pain or treat a specific medical condition (Oronsky Paragraph 0076) as, Yuzhakov teaches drug delivery but does not specify specific drugs or treatment sites.
Regarding claim 15, Oronsky further teaches wherein the applying the device to the area of skin includes applying it to a lower lumbar region of the spine (Paragraph 0188).
Regarding claim 16, Oronsky further teaches wherein applying the device to the area of skin includes applying it to a cervical region of the spine (Paragraph 0153; 0155).
Regarding claim 17, Oronsky further teaches wherein the microstructure device remains on the skin for a period of one hour to one week (Paragraph 0062), which encompasses the claimed time frames of 1 hour to 10 days; 8 hours to 6 days; and one day to 5 days.
Regarding claim 18, as best understood in view of the 112(b) issues above, the combination of Yuzhakov and Oronsky teaches wherein applying the device to the area of skin includes penetrating a range of two to 1,000 microstructures into the area of skin to treat pain generated by the underlying tissue, muscle, or joint associated with the spine (Figure 2A) (Figure 2A shows a plurality of microneedles in a range of 2 to 1000).
Regarding claim 19, Yuzhakov further discloses wherein the penetrating each microstructure of the plurality of microstructures into the area of skin includes insertion of each microstructure into an upper dermis layer of skin (Paragraph 0018; 0070).
Regarding claim 20, Yuzhakov further discloses wherein the applying the device to the area of skin includes adhering the adhesive layer of the backing to skin surrounding the area of skin (Paragraph 0049; 0052).
Regarding claim 21, As best understood in view of the 112(b) issues above, the combination of Yuzhakov and Oronsky further discloses wherein applying the device to the area of skin includes penetrating at least twenty microstructures into the area of skin to treat pain generated by the underlying tissue, muscle, or joints associated with the spine (Figure 2A) (Figure 2A shows a plurality of microneedles including at least twenty microneedles).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 4, 6-7, 14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 11986613 B2 in view of Oronsky et al. (US 20100042137 A1).
Regarding claim 2, claim 1 of US 11986613 B2 claims a method of reducing or preventing pain or inflammation using a device comprising (Col 32, line 60-61):
a foundation interconnecting a plurality of spring structures (Col 32, line 62-63);
a backing including an adhesive layer, the foundation affixed to the backing (Col 32, line 64-65); and
a plurality of microstructures arrayed on the foundation, each microstructure of the plurality of microstructures extending from the foundation adjacent to a spring structure of the plurality of spring structures (Col 32, line 66- Col 33, line 2);
the method comprising:
applying the device to an area of skin adjacent underlying tissue (Col 33, line 4); and
penetrating each microstructure of the plurality of microstructures into the area of skin (Col 33, line 6-7).
US 11986613 B2 fails to explicitly claim applying the device to an area of skin adjacent underlying tissue to treat pain originating from the underlying tissue, muscle, joint, tendon, ligaments, or bursa.
However, Oronsky is directed to a needle and patch system and teaches applying the device (200+500) to an area of skin adjacent underlying tissue to treat pain originating from the underlying tissue, muscle, joint, or tendon (Paragraph 0011; 0026; 0051; 0062; 0111).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify US 11986613 B2 to include applying the device to an area of skin adjacent underlying tissue, muscle, joint, or tendon to treat pain originating from the underlying tissue, muscle, joint, or tendon, as taught by Oronsky, as both references and the claimed invention are directed to drug delivery patches. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 11986613 B2 with the teachings of Oronsky by incorporating a method of reducing or preventing pain or inflammation comprising applying the device to an area of skin adjacent underlying tissue, muscle, joint, or tendon to treat pain originating from the underlying tissue, muscle, joint, or tendon in order to relieve pain or treat a specific medical condition (Oronsky Paragraph 0076).
Regarding claim 4, see claim 3 of US 11986613 B2.
Regarding claim 6, see claim 2 of US 11986613 B2.
Regarding claim 7, see claim 4 of US 11986613 B2.
Regarding claim 14, claim 1 of US 11986613 B2 claims a method of reducing or preventing pain or inflammation using a device comprising (Col 32, line 60-61):
a foundation interconnecting a plurality of spring structures (Col 32, line 62-63);
a backing including an adhesive layer, the foundation affixed to the backing (Col 32, line 64-65); and
a plurality of microstructures arrayed on the foundation, each microstructure of the plurality of microstructures extending from the foundation adjacent to a spring structure of the plurality of spring structures (Col 32, line 66- Col 33, line 2);
the method comprising:
applying the device to an area of skin adjacent underlying tissue (Col 33, line 4); and
penetrating each microstructure of the plurality of microstructures into the area of skin (Col 33, line 6-7).
US 11986613 B2 fails to explicitly claim a backing including a non-woven material and applying the device to an area of skin adjacent underlying tissue to treat pain originating from the underlying tissue, muscle, or joints, associated with the spine.
However, Oronsky teaches a backing (502) including a non-woven material (elastomer) (Paragraph 0065) and applying the device (500) to an area of skin adjacent a spine of a patient to treat pain originating from underlying tissue, muscle, or joints associated with the spine (Paragraph 0011; 0161; 0163-164; 0230).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 11986613 B2 with the teachings of Oronsky by incorporating applying the device to an area of skin adjacent a spine of a patient to treat pain originating from underlying tissue, muscle, or joints associated with the spine in order to relieve pain or treat a specific medical condition (Oronsky Paragraph 0076) and incorporating a backing including a non-woven material in order to serve as a protective covering to prevent loss of agent and/or carrier via transmission through the upper surface of the patch (Oronsky Paragraph 0065).
Regarding claim 17, see claim 2 of US 11986613 B2.
Regarding claim 18, see claim 4 of US 11986613 B2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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