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 .
Response to Amendment
This office action is responsive to the amendment filed on 4/8/26. As directed by the amendment: claims 1, 4-6, 9, and 10 have been amended, 2, 3, 7, 8, and 11-15 have been cancelled, and new claims 16 and 17 have been added. Thus, claims 1, 4-6, 9, 10, 16, and 17 are presently pending in this application.
The amendments to the drawings are sufficient to overcome the drawing objections from the previous action.
The claim objections from the previous action are withdrawn in light of the cancellation of claims 11-15.
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 and 10 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.
Regarding claims 5 and 10, it is unclear how to interpret the phrase “is comprises”, which is grammatically correct to the point where it cannot be properly interpreted. It remains unclear from the claim language as presented what the relationship is between the originally filed medical patch port holder and the subsequently recited rotatable medical patch port holder, the phrase “is comprises” failing to provide any further clarity on the matter relative to the previously presented language. It is noted that this language reflects an amendment made to claims 5 and 10 that is not properly notated using underlining/strikethrough/etc. For the purposes of examination, the “rotatable” limitation will be interpreted as further limiting the previously recited medical patch port holder.
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, 4-6, 9, 10, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nielson et al. (US 20100137829).
Regarding claim 1, Nielson et al. discloses A medical patch port for providing injection access (1, fig. 2-7; first embodiment of an injection gateway 1 comprises a base part which is secured to a user’s skin, par. 0047) to a flexible vessel comprising a solution (Note: “to a flexible vessel comprising a solution” is considered an intented use, and Nielson’s gateway is considered capable of use “to a flexible vessel comprising a solution” since it is capable of providing injection access to the skin, Abstract; alternatively, “flexible vessel” is the living body to which the device is implanted, and “solution” is the various solutions contained within the human body), the medical patch port comprising: an adhesive (1 comprises a base part which is secured to the user’s skin via an adhesive layer 4, par. 0047); a medical patch port holder 5; and a pierceable injection site component (comprising 2, 8, and 13), wherein the pierceable injection site component is angled upward relative to the medical patch port (see fig. 2-7, angled directly upward, facing in a direction roughly perpendicular to the width of the port as a whole).
Regarding claim 4, Nielson et al. discloses said medical patch port comprises a sliding component (portions of 5 which slide relative to 8) to provide access to an injection site 9/10 (see fig. 2-7; par. 0048, 0053).
Regarding claim 5, as best understood, Nielson et al. discloses said medical patch port holder is comprises a rotatable medical patch port holder (par. 0048, 0053).
Regarding claim 6, Nielson et al. discloses a method for providing a re-sealable injection site (1, fig. 2-7; first embodiment of an injection gateway 1 comprises a base part which is secured to a user’s skin, par. 0047) on a vessel comprising a solution (Note: “to a flexible vessel comprising a solution” is considered an intended use, and Nielson’s gateway is considered capable of use “to a flexible vessel comprising a solution” since it is capable of providing injection access to the skin, Abstract; alternatively, “flexible vessel” is the living body to which the device is implanted, and “solution” is the various solutions contained within the human body), said method comprising applying to an intended injection site a medical patch port (1, fig. 2-7; first embodiment of an injection gateway 1 comprises a base part which is secured to a user’s skin, par. 0047) comprising an adhesive (1 comprises a base part which is secured to the user’s skin via an adhesive layer 4, par. 0047), a medical patch port holder 5, and a pierceable injection site component (comprising 2, 8, and 13), wherein the pierceable injection site component is angled upward relative to the medical patch port (see fig. 2-7, angled directly upward, facing in a direction roughly perpendicular to the width of the port as a whole).
Regarding claim 9, Nielson et al. discloses said medical patch port comprises a sliding component (portions of 5 which slide relative to 8) to provide access to the re-sealable injection site (see fig. 2-7; par. 0048, 0053).
Regarding claim 10, as best understood, Nielson et al. discloses said medical patch port holder is comprises a rotatable medical patch port holder (par. 0048, 0053).
Regarding claim 16, Nielson et al. discloses the medical patch port holder and the pierceable injection site component comprise a single part (any individual part of these components identifiable in fig. 2-7 is a “single part” of the medical patch port holder and the pierceable injection site component), and wherein the single part is 2K molded (each single part identified above is molded, see fig. 2-7, and being disclosed as being formable from plastic, see par. 0049-0050, fully capable of being formed by such a process, this limitation being a product-by-process limitation).
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.
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) 16 (in the alternative) is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielson et al. in view of Jalandhara et al. (US 20170000997).
Regarding claim 16, in addition to the analysis of Nielson et al. under 35 U.S.C. 102 above, Jalandhara et al. further teaches interchangeable types of molding useable for medical devices, including 2K or “two-shot” molding (par. 0038). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize any known, appropriate plastic molding process, including 2K molding as taught by Jalandhara et al., to form any of the single parts identified in Nielson et al., since such a modification is a simple substitution of one known molding method for another to yield a predictable result of a molded component.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nielson et al.
Regarding claim 17, Nielson et al. teaches an angle of incline of the pierceable injection site component (specifically the angled portion of 8 of the pierceable injection site component, see at least fig. 2 and 3), but fails to explicitly disclose the angle is between 75 and 35 degrees. However, there is no evidence of record that establishes that changing the angle would result in a difference in function of the Nielson et al. device. Further, a person having ordinary skill in the art, being faced with modifying the angle of Nielson et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle may “for example” be within the claimed range (par. 0030-0032), and thus there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angle of Nielson et al. to be between 75 and 35 degrees as an obvious matter of design choice within the skill of the art.
Response to Arguments
Applicant's arguments filed 4/8/26 have been fully considered but they are not persuasive.
Applicant argues, on pg. 6-7 of the Remarks, that Nielson et al. fails to disclose the newly amended limitation of “angled upwards”. Examiner respectfully disagrees, noting that the scope of the limitation as claimed is more broad than what is argued by applicant. In particular, an element that faces directly upward relative to the device as a whole is considered to read on “angled upward” in that it is directed/facing upward relative to the device as a whole, and the direction of facing being angled roughly perpendicular to the device as a whole, or relative to the width of the device as a whole.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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