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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 7, 2026 has been entered.
Response to Amendment
Claims 16, 18-24, 26-36 are pending in the application. Claims 26-35 are withdrawn. Claim 16 has been amended. Claims 1-15, 17, and 25 are cancelled. Claims 16, 18-24 and 36 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 16, 18-23, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant Yang et al (US PG Pub 2018/0193026) in view of Hannes et al (US PG Pub 2014/0058498).
PNG
media_image1.png
411
668
media_image1.png
Greyscale
Regarding claim 16, Yang teaches a medical set (See Figs. 3A, 11A, and 11E) for treatment1 of an aneurysm comprising:
a main catheter (104) (See paragraphs [0094]-[0098]); and
a covering device (device 10) adapted to move through the main catheter to a treatment site to cover the aneurysm (See paragraphs [0094]-[0098]; Figs. 12A-12I), the covering device adapted to connect to a transport wire (24) (See paragraphs [0059], [0094]-[0098]), the covering device including a self-expandable mesh structure (See Figs. 11A & 11E, note lattice structure; see also paragraph [0093] which states the device is self-expanding) having webs (struts) connected together in one piece and that delimit inner cells and edge cells (See annotated Fig. 11E above), wherein at a longitudinal end of the mesh structure, the edge cells form a closed edge cell ring connected to the inner cells on only one side (See Figs. 11A and 11E, note the edge cell struts are connected to the inner cell struts on only one side),
wherein the mesh structure is provided with a covering (60) having at least 10 pores (See Figs. 2A and 11E; paragraph [0053]) over an area of 100,000 µm2 (See paragraph [0062] which provides a range of lengths2 and diameters for the device) where ingress of a blood flow into the aneurysm is reduced by the covering (See paragraphs [0057]-[0058] which state the covering over the central section has a higher density to facilitate retention of coils within the aneurysm sac. It is noted that a higher density/less porous covering will also reduce blood flow into the aneurysm. See also paragraph [0053] which states the central section promotes endothelialization near the aneurysm neck which in turn occludes the aneurysm from the blood vessel thus reducing blood flow into the aneurysm); wherein at least one inner cell of the mesh structure is at least partially covering-free (See Fig. 11E, paragraphs [0091]-[0092]) and wherein perfusion of side branches located3 next to or near the aneurysm is maintained by the at least one partially covering free inner cell. (See paragraphs [0065] which states the stent and covering are configured such that “a fully patent central lumen 40 throughout the axial length of the device 10”)
Yang does not explicitly teach the covering is produced from4 an electrospun fabric having pores of irregular sizes wherein the pore size is at least 15µm2. Yang teaches the covering may be a variety of known suitable polymeric materials including various fluoropolymers and silicones (See paragraph [0087]) applied by a variety of processes including vapor deposition, spray coating, dip coating, spin coating, sputter deposition (See paragraphs [0008]; [0044]; [0045]; [0047]). Yang also teaches the covering (coating) may be applied differently to different regions and may have variable porosity (See paragraph [0053] and [0091]) and that additional perforations of varying sizes may be added to the covering (See paragraph [0053]).
Hannes teaches an analogous medical set for treatment of an aneurysm (See paragraphs [0002]-[0003]) featuring a covering device (stent) made of a self-expandable mesh (stent) having webs connected together (See paragraphs [0033] and [0039]) and covered with an electrospun fabric (membrane) (See paragraphs [0012] and [0018]) having pores of irregular sizes5 where the covering as at least 10 pores with a size of at least 15µm2. (See Figs. 4-6; paragraphs [0014]-[0016]). Hannes teaches a pore size of at least 15µm2 is especially favorable for the ingrowth of endothelial cells (See paragraph [0016]) Hannes teaches the membrane may be formed by immersion or spray coating (See paragraph [0011]), but that the membrane is most preferably formed by electrospinning (See paragraphs [0012]). Electrospinning is known to produce a thin and uniform membrane which bonds with the stent framework and allows for control of the degree of porosity as desired. (See paragraphs [0012], [0025], [0026], and [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Yang so as to apply the covering via electrospinning as taught by Hannes such that the covering pore size is at least 15µm2 since electrospinning is known to be an advantageous and preferably means of applying a coating to a stent and pores of at least 15µm2 are known in the art to be optimally sized for the ingrowth of endothelial cells. Using an electrospun process as taught by Hannes to form the covering in the device of Yang is a simple substitution of one known element for another to obtain predictable results. Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. Yang expressly contemplates using a variety of different processes. (See paragraph [0045]). Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183) As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
As disclosed, the number of pores of a particular size over an area of the electrospun covering is disclosed to be a result effective variable which assists with colonization by endothelial cells and sufficient perfusion of the covering by blood. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Yang to have an electrospun covering which has at least 10 pores with a size of at least 15µm2 over an area of 100,00µm2, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of pores of a particular size over an area as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Regarding claim 18, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering device (10) is reversibly connectable to the transport wire (24) and, in an expanded state, is open on both end sides and perfusible by blood. (See Figs. 11A and 11E; paragraphs [0059]; [0064]; [0077]; [0093]-[0099]).
Regarding claim 19, modified Yang teaches the medical set as required by claim 16 above and further teaches the webs (struts) of the inner cells are respectively associated with one of a further inner cell or edge cell (note the inner cells are those directly inward at the outer band and are associated with further inner cells). (See Fig. 11E as annotated above; paragraphs [0093]-[0099])
Regarding claim 20, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering ends at the webs of the inner cells are free from the covering such that the covering does not protrude into the at least one inner cell. (See Fig. 11E; paragraphs [0091]-[0092])
Regarding claim 21, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering at least partially overlaps the webs of the at least one inner cell such that part of the covering protrudes into the at least one inner cell which is free from the covering. (See Fig. 11E; paragraphs [0091]-[0092]; note the covering is on the struts surrounding the uncovered cells)
Regarding claim 22, modified Yang teaches the medical set as required by claim 16 above and further teaches a plurality6 of inner cells immediately adjacent in a circumferential direction of the mesh structure is covering-free. (See annotated Fig. 11E ; paragraphs [0091]-[0092])
Regarding claim 23, modified Yang teaches the medical set as required by claim 16 above and further teaches a plurality7 of inner cells immediately adjacent in a longitudinal direction of the mesh structure is covering-free. (See annotated Fig. 11E; paragraphs [0091]-[0092])
Regarding claim 36, modified Yang teaches the medical set as required by claim 16 above and further teaches wherein the edge cells respectively have two webs (struts) which are not associated with one of other inner cells or edge cells (See annotated Fig. 11E.)
Claim 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant Yang et al (US PG Pub 2018/0193026) in view of Hannes et al (US PG Pub 2014/0058498) as applied to claim 16 above and further in view of previously cited Cox et al (US PG Pub 2017/0245862).
Regarding claim 24, modified Yang teaches the medical set as required by claim 16 above and further teaches the covering extends by at most 50% over a circumference of the mesh structure. (See paragraph [0092] which states the covering may be applied only on a portion of the device or on selective sections of the device. See also paragraphs [0053] and [0063]).
Alternatively, Cox teaches an analogous medical set for treating aneurysms featuring a catheter (110), a covering device (100) connected to a transport wire (112) the covering device including a self-expandable mesh structure (132) having webs (struts) that delimit inner cells (near the center of the device) and outer cells (at the respective ends of the device) where the mesh structure (132) is provided with a covering (134) which extends along only a portion of the middle of the device and covers less than 50% over a circumference of the mesh structure (See Figs. 16 and 18).
It would have been obvious to one of ordinary skill in the art at the time of invention to further modify Yang to incorporate the teachings of Cox such that the covering extends by at most 50% over a circumference of the mesh structure since Yang already contemplates having the covering extend only over certain desired portions of the device (See paragraphs [0091]-[0092]) and Cox teaches having a covering which only spans the opening of the aneurysm is advantageous for redirecting flow and reducing the likelihood the aneurysm will burst. (See paragraphs [0094]-[0095]; [0098]).
Response to Arguments
Applicant's arguments filed April 7, 2026 have been fully considered but they are not persuasive.
Applicant first argues that Yang teaches away from having perfusion of side branches located near the aneurysm by the at least one partially covering free inner cell. This is unpersuasive. Yang explicitly teaches “The tapered sections 28, 30 may extend axially and circumferentially to terminate in apexes 26, 27, respectively, that are aligned along the outer circumference of the central section 20, to leave a fully patent central lumen 40 throughout the axial length of the device 10, without any cross struts to create flow turbulence. A device with an unobstructed lumen may reduce the thrombogenicity of the device.” (See paragraph [0065]; see also paragraphs [0091]-[0092] which discuss variable porosity at different sections of the device). Since the cells near the ends of the device are covering free and the lumen through the device is fully open for blood to flow, the device meets the structural limitations as claimed and is thus deemed to meet the functional intended use recited in the claim.
It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
Applicant next argues that the intent of Hannes is to promote tissue ingrowth, not maintain perfusion from collateral vessels. This point is moot. Firstly, the determination of the level of ordinary skill in the art is not an inquiry into the thoughts of a specific inventor, but rather the relevant art as a whole at the time of invention. (See MPEP §2141.03). Secondly, Yang teaches all of the structural elements, namely the at least one inner cell being at least partially covering free and perfusion of the side branches located next to or near the aneurysm is maintained by the at least one partially covering free inner cell. Hannes is not relied upon for teaching at least one inner cell being covering free.
Applicant next argues Hannes is not combinable with Yang because Hannes teaches the stent is completely covered by the electrospun membrane. This is unpersuasive. Yang teaches the coating (covering) may be applied in a variety of ways (See paragraph [0045]) including vapor deposition, spray coating, dip coating, spin coating, sputter deposition (See paragraphs [0008]; [0044]; [0045]; [0047]) and also teaches the covering may be made porous with differing or a gradient of porosity along the length. (See paragraph [0053] and [0091]) and that additional perforations of varying sizes may be added to the covering (See paragraph [0053]). Specifically, Yang states:
“Perforations may be imparted by laser or mechanical perforation through the sleeve 60 or by other suitable means. Perforations may be used to make variable porosity sleeves the same as or similar to perforations applied to the film coating described elsewhere herein. Use of a sleeve 60 may allow use of a lower mesh density (i.e. greater porosity) in the underlying device 10 (e.g., 25%, 30%, 40%, 50% porosity or greater).In some embodiments, the sleeve 60 and/or coating may be applied to the entire length of the device 10. The sleeve 60 and/or coating may provide coverage over all or substantially all of the interstitial gaps in the mesh of the device 10. In some embodiments, the coating may be applied only over a portion of the device 10. For example, the sleeve 60 and/or coating 11 may be applied over a middle section of the device configured to be placed proximate the aneurysm (e.g., the middle 10%, 20%, 25%, 30%, 40%, 50%, etc. of the device). In some embodiments, selective sections of the device may be coated.” (See paragraphs [0091]-[0092])
Hannes teaches the membrane may be formed by immersion or spray coating (See paragraph [0011]), but that the membrane is most preferably formed by electrospinning (See paragraphs [0012]). Electrospinning is known to produce a thin and uniform membrane which bonds with the stent framework and allows for control of the degree of porosity as desired. (See paragraphs [0012], [0025], [0026], and [0040]). Hannes is relied upon for the teaching that electrospinning is an analogous means to immersion (dip) or spray coating to create a desirable coating on a stent device for use near an aneurysm. Hannes is not relied upon for covering free inner cells which allow perfusion into branching vessels since Yang already teaches that limitation.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, electrospinning is widely known and used in the art to create coverings on implantable medical devices. Additionally, electrospinning is known to be an obvious variant of dip or spray coating (See Hannes paragraph [0011]).
In response to applicant's argument that it would not be obvious to combine Hanne’s teaching of electrospinning with the device as taught by Yang, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Inherent in the combination of references is the understanding that one skilled in the art would know and understand a suitable way to combine the teachings so as to make an appropriately sized and proportioned device with the desired characteristics from each of the references. Further KSR International Co. v. Teleflex, Inc. 82 USPQ2d 1385, 1396-1397 (2007) (as recited in the MPEP §2141.03(I)) states “a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton”. And further states “in many cases, a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle”.
Applicant next argues the combination of Yang and Hannes necessarily requires a fully covered stent, however this is not persuasive. Yang expressly contemplates a wide variety of ways to apply the coating. “The coating material(s) may be applied to the device surface according to a number of processes, depending on the composition selected. These processes may include but are not limited to:…” (See paragraph [0045]) Yang also states “Other processes for forming a coating which extends across one or more of the interstitial spaces may be used as well.” (See paragraph [0053]). Yang goes on to state:
“In some embodiments, the film may be selectively removed by laser after the film has been formed on the device. The film may have variable regions of porosity. For example, the film may be made (e.g., with a laser) to have a gradient of porosity along a length or a portion of the length of the device. The perforations made by the laser or other means may be positioned within the interstitial gaps of the meshed device. The perforations may be of various sizes.” (See paragraph [0053]).
Applicant next argues the rejection contains a conversion error. The error has been fixed above. The calculation error does not impact the underlying logic of the rejection. It is noted that applicant’s argument regarding the conversion error itself contains multiple typographical errors which makes the argument difficult to precisely understand.
Applicant’s next argument is that pore density is an inherent structural characteristic not a result effective variable. Applicant states “However, pore density, size distribution, and irregularity in electrospun fabrics are interrelated consequences of electrospinning process parameters - fiber diameter, collection time, spinning voltage, and collector distance. These are not independently adjustable 'dials.' Adjusting one parameter necessarily affects the others.”
It is well within the ordinary level of skill in the art to select the appropriate or desired porosity of a stent covering depending upon the particular parameters of a patient. Yang explicitly teaches adjusting porosity along the stent through various means. It is noted that just because it is complicated to adjust the porosity of an electrospun fabric, does not mean it is not a result effective variable or that it would not be obvious. Again, the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant's argument suggests that the proposed modification involves tradeoffs; however, such considerations do not necessarily prevent the proposed combination. See Medichem, S.A. v. Rolabo, S. L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) ("a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine"); Winner Int 'l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n. 8 (Fed. Cir. 2000) ("The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another."). See MPEP §2141.02 and §2143.01 The Examiner has identified an advantage to having the covering be an electrospun fabric -i.e., a thin, uniform membrane . We note that Hannes explicitly teaches the desirability of electrospinning is that is known to produce a thin and uniform membrane which bonds with the stent framework and allows for control of the degree of porosity as desired. (See Hannes paragraphs [0012], [0025], [0026], and [0040]). That this advantage comes at the purported expense of the membrane must cover the entire stent as argued by applicant does not necessarily mean that the modification would not have been obvious. Further, since Yang expressly contemplates adding perforations to the covering via laser or other mechanical means after the covering is in place, applicant’s argument falls flat.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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 call the examiner at the number listed above. Applicant may 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, Melanie Tyson can be reached at 571-272-9062. 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.
/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 It is noted that this is a recitation of intended use in the preamble and not given full patentable weight, in that the prior art is not required to disclose this function/method of use. Since the body of the claim in the instant case fully and intrinsically sets forth all the limitations of the claimed invention, the preamble recitation of intended use is not considered a claim limitation. Additionally, MPEP 2111.02(II) states: “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)”. In the instant case, Yang expressly contemplates using the medical set to treat aneurysms (See Title, Abstract, Summary of the Invention, etc.)
2 Paragraph [0062] states the stent may be at least 5mm to more than 25mm in length and at least 2mm to more than 10mm in diameter. Using the standard, known equation for calculating the area of a cylinder (
A
=
2
π
r
h
+
2
π
r
2
), this results in a range of area between roughly 37.6991mm2 to 942.4778mm2 which is clearly larger than the claimed area value of at least 100,000µm2 which is equal to .1mm2. It is noted neither the claim, nor the originally filed specification give any reason for or criticality to the parameter of the cover having at least 10 pores with a size of at least 15 µm2 over an area of 100,000µm2
3 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). Since Yang teaches blood can flow fully through the length of the device, it would be capable of perfusion into side branches when implanted in a location adjacent side branches. This is a recitation of intended use. The device of Yang is fully capable of performing the recited intended use.
4 It is noted that “a covering produced from a fabric…wherein the covering is configured as an electrospun covering…” is a product-by-process limitation, and as such only the product will be examined. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)); see MPEP §2113). The court further stated in Brown. “[w]e are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product by process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 173 USPQ 685, 688 (CCPA 1972)
5 It is noted that the process of electrospinning is known to inherently create pores of irregular sizes. (As stated in applicant’s arguments page 7 dated 9/25/2025)
6 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, a “plurality” is two or more. As seen in annotated Fig. 11E there are at least two uncovered inner cells which are immediately adjacent to one another in a circumferential direction.
7 See footnote 6 above
Prosecution Insights