DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 23 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 23 is dependent on a canceled claim 1. For the purpose of the examination, it is assumed that claim 23 is depends on claim 16. Clarification is requested via amendments.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 16-35 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Colvin JR (USPN 20040176669).
It is noted that claims stated below are a product by process claims (See MPEP 2113), and the product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Therefore, Examiner interprets the structure of claim 16 as “the tissue-integrating sensor having a plurality of hollow, interconnected pores in the sensor scaffold such that capillaries can grow directly into the sensor scaffold such that the sensing moiety provides detection of the analyte when the tissue-integrating scaffold is placed into the tissue of a subject”. Since the tissue-integrating sensor of the prior art is structurally identical to the tissue-integrating sensor as claimed, there is no structural difference between the manufacturing process of the sensor of the prior art and the manufacturing process of the sensor as claimed.
With respect to claim 16, Colvin, JR discloses the tissue-integrating sensor having a plurality of hollow, interconnected pores in the sensor scaffold such that capillaries can grow directly into the sensor scaffold (The sensor/tissue interface layer 36 includes three sublayers 36a, 36b, and 36c wherein the sublayer 36a, a layer which promotes tissue ingrowth, preferably is made from a biocompatible material that permits the penetration of capillaries 37 into it [0084]). Colvin, JR discloses the sensing moiety (indicator molecule 116 figure 7,) provides detection of the analyte when the tissue-integrating scaffold is placed into the tissue of a subject (the indicator molecule 116 provides detection of glucose, [0118]-[0120]).
Regarding claim 17, Colvin JR discloses that the sensor scaffold is a hydrogel ([0167] line 8).
Regarding claim 18, Colvin JR discloses the sensing moiety is embedded within the sensor scaffold (figures 7A-B).
Regarding claim 19, Colvin JR discloses the sensing moiety is attached to an exterior of the scaffold (figures 4, 7A-B).
Regarding claim 20, Colvin JR discloses constructed by coating an exterior of the sensor scaffold after dissolving the template beads (Since the sensing moiety structure is identical to the prior art, the process as claimed is identical to the process of the prior art’ See MPEP 2113 product by process).
Regarding claim 21, Colvin JR discloses the template beads are microspheres (the sensing moiety is a microsphere as shown in figures 4, 7A-B).
Regarding claim 22, Colvin JR discloses calibration moiety is combined with the scaffold polymer precursor and the sensing moiety ([0107]).
Regarding claim 23, Colvin JR discloses a system for detecting an analyte, the system comprising a tissue-integrating sensor according to claim 16; and a module that generates or measures the signal produced by the sensing moieties (Colvin JR discloses “photosensitive element 20, e.g. a photodetector, which, in the case of a fluorescence-based sensor, is sensitive to fluorescent light emitted by the indicator molecules 16 such that a signal is generated in response thereto that is indicative of the level of fluorescence of the indicator molecules”; [0074]).
Regarding claim 24, Colvin JR discloses a component selected from the group consisting of a detector, a signal receiver, a signal transmitter, a signal processing component, an energy storage component, a data storage component, a data transmitter, a data display device, a data processing component and combinations thereof ([0078], figure 1).
Regarding claim 25, Colvin JR discloses method for detection of an analyte in a tissue of a subject, the method comprising integrating a sensor according to claim 16 into the tissue and detecting the presence of the analyte (Colvin JR discloses detecting a presence of glucose, [0080]).
Regarding claim 26, Colvin JR discloses the plurality of hollow, interconnected pores are configured such that capillaries can grow in close proximity to the one or more sensing moieties in all regions of the tissue-integrating sensor (The sensor/tissue interface layer 36 includes three sublayers 36a, 36b, and 36c wherein the sublayer 36a, a layer which promotes tissue ingrowth, preferably is made from a biocompatible material that permits the penetration of capillaries 37 into it [0084]).
Regarding claim 27, Colvin JR discloses the plurality of hollow, interconnected pores are configured such that, when the tissue-integrating sensor is placed into a tissue of a subject, capillaries can grow into the hydrogel scaffold such that an average distance from any point of the tissue-integrating sensor to a first blood vessel is no greater than 100 microns more than an average distance from any point in the tissue into which the tissue-integrating sensor is placed to a second blood vessel ([0081], [0165]).
Regarding claim 28, Colvin JR discloses the tissue-integrating sensor is configured to be placed directly into a tissue of a subject devoid of additional sensor elements (the sensor only includes the electronics such as light source, detector shown in figure 1. There are no additional sensor elements in the sensor); the tissue-integrating sensor alone is configured to be illuminated by an excitation light produced by an interrogator while the tissue-integrating sensor is within the tissue of the subject, and the interrogator is external to the subject’s body; and the tissue-integrating sensor alone is configured to produce the signal in response to the excitation light such that the signal is detectable by a detector external to the subject’s body ([0074]).
Regarding claim 29, Colvin JR discloses the tissue-integrating sensor is configured to contact only tissue when the tissue-integrating sensor is placed into a tissue of a subject ([0074]).
Regarding claim 30, Colvin JR discloses the tissue-integrating scaffold is permeable to the analyte ([0074]).
Regarding claim 31, Colvin JR discloses the hydrogel scaffold has a single layer (figure 1).
Regarding claim 32, Colvin JR discloses the tissue-integrating sensor is cylindrical and has a diameter of 500 micrometers or less (figure 1, [0081]).
Regarding claim 33, Colvin JR discloses the sensor scaffold is constructed of a first scaffold material, the tissue-integrating sensor further constructed by coating an exterior of the sensor scaffold with a second scaffold material after dissolving the template beads (the sensor scaffold has first scaffold material and a second scaffold material as shown in figure 3 and [0075]).
Regarding claim 34, Colvin JR discloses the first scaffold material is at least one of a hydrogel or a collagen ([0167] line 8, [0074]).
Regarding claim 35, Colvin JR discloses the second scaffold material is at least one of a hydrogel or a collagen ([0167] line 8, [0074]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791